Recalls / —

—#200606

Product

ARROW Endurance Extended Dwell Peripheral Catheter System

FDA product code

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K163513

Affected lot / code info

a. Product Code: ASK-00620-MSH. UDI (Batch Number): (01)10801902212105 (17)240630 (11)220914 (10)13F22H0910 (13F22H0910), (01)10801902212105 (17)240630 (11)221118 (10)13F22L0492 (13F22L0492); b. Product Code: ASK-00620-TMC. UDI (Batch Number): (01)10801902193022 (17)230531 (10)13F21J0257 (13F21J0257), (01)10801902193022 (17)230731 (11)220511 (10)13F22E0014 (13F22E0014), (01)10801902193022 (17)230731 (11)220527 (10)13F22E0263 (13F22E0263), (01)10801902193022 (17)240229 (11)220729 (10)13F22G0191 (13F22G0191), (01)10801902193022 (17)240430 (11)221012 (10)13F22K0352 (13F22K0352), (01)10801902193022 (17)240430 (11)230113 (10)13F23A0220 (13F23A0220), (01)10801902193022 (17)240731 (11)230309 (10)33F23B1020 (33F23B1020); c. Product Code: ASK-00622-MSH. UDI (Batch Number): (01)10801902212112 (17)240630 (11)220909 (10)13F22H0912 (13F22H0912), (01)10801902212112 (17)240630 (11)221114 (10)13F22L0361 (13F22L0361); d. Product Code: ASK-00818-IVA. UDI (Batch Number): (01)10801902144499 (17)231031 (10)13F21L0242 (13F21L0242), (01)10801902144499 (17)240229 (11)220324 (10)13F22C0480 (13F22C0480); e. Product Code: ASK-00820-FLH. UDI (Batch Number): (01)10801902146318 (17)230630 (11)220124 (10)13F22A0808 (13F22A0808), (01)10801902146318 (17)230930 (11)220530 (10)13F22E0250 (13F22E0250), (01)10801902146318 (17)231231 (11)220606 (10)13F22F0034 (13F22F0034), (01)10801902146318 (17)240331 (11)221107 (10)13F22K1112 (13F22K1112), (01)10801902146318 (17)240331 (11)221122 (10)13F22L0530 (13F22L0530), (01)10801902146318 (17)240831 (11)230309 (10)33F23B1019 (33F23B1019); f. Product Code: ASK-00820-TMC. UDI (Batch Number): (01)10801902192988 (17)230731 (11)220309 (10)13F22B0679 (13F22B0679), (01)10801902192988 (17)230731 (11)220412 (10)13F22C0817 (13F22C0817), (01)10801902192988 (17)230731 (11)220527 (10)13F22E0442 (13F22E0442), (01)10801902192988 (17)230731 (11)220715 (10)13F22F0601 (13F22F0601), (01)10801902192988 (17)240229 (11)220924 (10)13F22J0341 (13F22J0341), (01)10801902192988 (17)240430 (11)221107 (10)13F22K1113 (13F22K1113), (01)10801902192988 (17)240430 (11)221114 (10)13F22L0266 (13F22L0266), (01)10801902192988 (17)240430 (11)221206 (10)13F22L0910 (13F22L0910), (01)10801902192988 (17)240731 (11)230309 (10)33F23B1025 (33F23B1025); g. Product Code: EDC-00620. UDI (Batch Number): (01)10801902132908 (17)230831 (10)14F18H0260 (14F18H0260), (01)10801902132908 (17)230831 (10)14F18H0451 (14F18H0451), (01)10801902132908 (17)200930 (10)14F18K0137 (14F18K0137), (01)10801902132908 (17)231031 (10)14F18L0078 (14F18L0078), (01)10801902132908 (17)201130 (10)14F18M0028 (14F18M0028), (01)10801902132908 (17)230531 (10)14F21E0292 (14F21E0292), (01)10801902132908 (17)230531 (10)14F21F0075 (14F21F0075), (01)10801902132908 (17)230531 (10)14F21F0129 (14F21F0129), (01)10801902132908 (17)230731 (10)14F21F0250 (14F21F0250), (01)10801902132908 (17)230731 (10)14F21G0240 (14F21G0240), (01)10801902132908 (17)230731 (10)14F21H0189 (14F21H0189), (01)10801902132908 (17)230831 (10)14F21H0220 (14F21H0220), (01)10801902132908 (17)230831 (10)14F21J0112 (14F21J0112), (01)10801902132908 (17)230930 (10)14F21J0169 (14F21J0169), (01)10801902132908 (17)230930 (10)14F21K0030 (14F21K0030), (01)10801902132908 (17)230930 (10)14F21K0053 (14F21K0053), (01)10801902132908 (17)231031 (10)14F21L0209 (14F21L0209), (01)10801902132908 (17)231031 (10)14F21L0210 (14F21L0210), (01)10801902132908 (17)231031 (10)14F21L0211 (14F21L0211), (01)10801902196368 (17)231231 (10)14F21M0098 (14F21M0098), (01)10801902196368 (17)231231 (10)14F21M0099 (14F21M0099), (01)10801902196368 (17)231231 (10)14F22A0008 (14F22A0008), (01)10801902196368 (17)240229 (10)14F22C0097 (14F22C0097), (01)10801902196368 (17)240229 (10)14F22C0098 (14F22C0098), (01)10801902196368 (17)240229 (10)14F22C0099 (14F22C0099), (01)10801902196368 (17)240229 (10)14F22C0100 (14F22C0100), (01)10801902196368 (17)240229 (10)14F22C0270 (14F22C0270), (01)10801902196368 (17)240331 (10)14F22C0271 (14F22C0271), (01)10801902196368 (17)240331 (10)14F22C0272 (14F22C0272), (01)10801902196368 (17)240331 (10)14F22D0083 (14F22D0083), (01)10801902196368 (17)240331 (10)14F22D0084 (14F22D0084), (01)10801902196368 (17)240430 (10)14F22E0009 (14F22E0009), (01)10801902196368 (17)240430 (10)14F22E0068 (14F22E0068), (01)10801902132908 (17)240430 (10)14F22E0125 (14F22E0125), (01)10801902196368 (17)240531 (10)14F22F0071 (14F22F0071), (01)10801902196368 (17)240630 (10)14F22F0333 (14F22F0333), (01)10801902196368 (17)240630 (10)14F22G0051 (14F22G0051), (01)10801902196368 (17)240630 (10)14F22G0052 (14F22G0052), (01)10801902196368 (17)240731 (10)14F22G0217 (14F22G0217), (01)10801902196368 (17)240731 (10)14F22G0218 (14F22G0218), (01)10801902196368 (17)240831 (10)14F22H0342 (14F22H0342), (01)10801902196368 (17)240930 (10)14F22J0279 (14F22J0279), (01)10801902196368 (17)240930 (10)14F22K0061 (14F22K0061), (01)10801902196368 (17)241031 (10)14F22K0210 (14F22K0210), (01)10801902196368 (17)241031 (10)14F22L0027 (14F22L0027), (01)10801902196368 (17)241031 (10)14F22L0028 (14F22L0028), (01)10801902196368 (17)241031 (10)14F22L0070 (14F22L0070), (01)10801902196368 (17)241031 (10)14F22L0071 (14F22L0071), (01)10801902196368 (17)241130 (10)14F22L0161 (14F22L0161), (01)10801902196368 (17)241231 (10)14F23A0058 (14F23A0058), (01)10801902196368 (17)241231 (10)14F23A0174 (14F23A0174), (01)10801902196368 (17)241231 (10)14F23A0175 (14F23A0175), (01)10801902196368 (17)241231 (10)14F23A0176 (14F23A0176), (01)10801902196368 (17)241231 (10)14F23A0177 (14F23A0177), (01)10801902196368 (17)241231 (10)14F23A0308 (14F23A0308), (01)10801902196368 (17)250131 (10)14F23B0201 (14F23B0201); h. Product Code: EDC-00620-B. UDI (Batch Number): (01)10801902133004 (17)230531 (10)13F21E0852 (13F21E0852), (01)10801902133004 (17)230531 (10)13F21F0212 (13F21F0212), (01)10801902133004 (17)230531 (10)13F21F0523 (13F21F0523), (01)10801902133004 (17)230630 (10)13F21G1197 (13F21G1197), (01)10801902133004 (17)230831 (10)13F21H1179 (13F21H1179), (01)10801902133004 (17)230831 (10)13F21J0282 (13F21J0282), (01)10801902133004 (17)230930 (10)13F21K0896 (13F21K0896), (01)10801902133004 (17)231130 (10)13F21M0122 (13F21M0122), (01)10801902133004 (17)231231 (10)13F22A0152 (13F22A0152), (01)10801902133004 (17)240229 (10)13F22B0677 (13F22B0677), (01)10801902133004 (17)240430 (10)13F22E0261 (13F22E0261), (01)10801902133004 (17)240630 (10)13F22G0196 (13F22G0196), (01)10801902133004 (17)240930 (10)13F22K0354 (13F22K0354), (01)10801902133004 (17)240930 (10)13F22K0563 (13F22K0563), (01)10801902133004 (17)241130 (11)221214 (10)13F22M0126 (13F22M0126), (01)10801902133004 (17)241231 (11)230105 (10)13F22M0468 (13F22M0468), (01)10801902133004 (17)250228 (11)230310 (10)33F23B1021 (33F23B1021); i. Product Code: EDC-00622. UDI (Batch Number): (01)10801902132922 (17)230531 (10)14F21D0276 (14F21D0276), (01)10801902132922 (17)230531 (10)14F21F0151 (14F21F0151), (01)10801902132922 (17)230630 (10)14F21G0117 (14F21G0117), (01)10801902132922 (17)230731 (10)14F21G0286 (14F21G0286), (01)10801902132922 (17)230831 (10)14F21H0218 (14F21H0218), (01)10801902132922 (17)230831 (10)14F21J0111 (14F21J0111), (01)10801902132922 (17)230930 (10)14F21K0051 (14F21K0051), (01)10801902132922 (17)231130 (10)14F21L0212 (14F21L0212), (01)10801902132922 (17)231130 (10)14F21L0218 (14F21L0218), (01)10801902196375 (17)231231 (10)14F21M0101 (14F21M0101), (01)10801902196375 (17)231231 (10)14F22A0055 (14F22A0055), (01)10801902196375 (17)240229 (10)14F22C0101 (14F22C0101), (01)10801902196375 (17)240430 (10)14F22E0008 (14F22E0008), (01)10801902196375 (17)240531 (10)14F22F0152 (14F22F0152), (01)10801902196375 (17)240731 (10)14F22G0219 (14F22G0219), (01)10801902196375 (17)240731 (10)14F22G0243 (14F22G0243), (01)10801902196375 (17)240831 (10)14F22J0148 (14F22J0148), (01)10801902196375 (17)241031 (10)14F22K0211 (14F22K0211), (01)10801902196375 (17)241130 (10)14F22M0119 (14F22M0119), (01)10801902196375 (17)241231 (10)14F23A0072 (14F23A0072); j. Product Code: EDC-00622-B. UDI (Batch Number): (01)10801902133028 (17)230831 (10)13F21J0635 (13F21J0635), (01)10801902133028 (17)240430 (10)13F22E0264 (13F22E0264), (01)10801902133028 (17)240831 (11)220928 (10)13F22J0565 (13F22J0565), (01)10801902133028 (17)241031 (11)221103 (10)13F22K1119 (13F22K1119), (01)10801902133028 (17)241130 (11)221214 (10)13F22M0124 (13F22M0124), (01)10801902133028 (17)241130 (11)230102 (10)13F22M0459 (13F22M0459); k. Product Code: EDC-00818. UDI (Batch Number): (01)10801902132946 (17)230531 (10)14F21F0077 (14F21F0077), (01)10801902132946 (17)230731 (10)14F21G0241 (14F21G0241), (01)10801902132946 (17)230731 (10)14F21H0187 (14F21H0187), (01)10801902132946 (17)230831 (10)14F21H0219 (14F21H0219), (01)10801902132946 (17)230831 (10)14F21J0110 (14F21J0110), (01)10801902132946 (17)231031 (10)14F21J0170 (14F21J0170), (01)10801902132946 (17)230930 (10)14F21K0054 (14F21K0054), (01)10801902132946 (17)231130 (10)14F21L0213 (14F21L0213), (01)10801902132946 (17)231130 (10)14F21L0214 (14F21L0214), (01)10801902132946 (17)231130 (10)14F21L0219 (14F21L0219), (01)10801902196382 (17)231231 (10)14F22A0189 (14F22A0189), (01)10801902196382 (17)231231 (10)14F22A0190 (14F22A0190), (01)10801902196382 (17)240229 (10)14F22C0102 (14F22C0102), (01)10801902196382 (17)240229 (10)14F22C0103 (14F22C0103), (01)10801902196382 (17)240229 (10)14F22C0104 (14F22C0104), (01)10801902196382 (17)240331 (10)14F22D0101 (14F22D0101), (01)10801902196382 (17)240430 (10)14F22E0010 (14F22E0010), (01)10801902132946 (17)240531 (10)14F22F0005 (14F22F0005), (01)10801902196382 (17)240531 (10)14F22F0006 (14F22F0006), (01)10801902196382 (17)240531 (10)14F22F0089 (14F22F0089), (01)10801902196382 (17)240630 (10)14F22G0123 (14F22G0123), (01)10801902196382 (17)240831 (10)14F22H0344 (14F22H0344), (01)10801902196382 (17)240831 (10)14F22J0208 (14F22J0208), (01)10801902196382 (17)240930 (10)14F22K0128 (14F22K0128), (01)10801902196382 (17)240930 (10)14F22K0129 (14F22K0129), (01)10801902196382 (17)241031 (10)14F22K0212 (14F22K0212), (01)10801902196382 (17)241031 (10)14F22K0213 (14F22K0213), (01)10801902196382 (17)241231 (10)14F23A0180 (14F23A0180), (01)10801902196382 (17)241231 (10)14F23A0309 (14F23A0309), (01)10801902196382 (17)250228 (10)14F23B0330 (14F23B0330); l. Product Code: EDC-00818-B. UDI (Batch Number): (01)10801902133042 (17)230531 (10)13F21F1022 (13F21F1022), (01)10801902133042 (17)230831 (10)13F21J0283 (13F21J0283), (01)10801902133042 (17)230930 (10)13F21K0047 (13F21K0047), (01)10801902133042 (17)231031 (10)13F21L0563 (13F21L0653), (01)10801902133042 (17)231231 (10)13F21M0598 (13F21M0598), (01)10801902133042 (17)240229 (10)13F22C0492 (13F22C0492), (01)10801902133042 (17)240430 (10)13F22E0440 (13F22E0440), (01)10801902133042 (17)240831 (11)220923 (10)13F22J0572 (13F22J0572), (01)10801902133042 (17)240930 (11)221021 (10)13F22K0681 (13F22K0681), (01)10801902133042 (17)241031 (11)221114 (10)13F22L0279 (13F22L0279), (01)10801902133042 (17)241130 (11)221213 (10)13F22M0125 (13F22M0125), (01)10801902133042 (17)250228 (11)230309 (10)33F23B1023 (33F23B1023); m. Product Code: EDC-00820. UDI (Batch Number): (01)10801902132960 (17)230831 (10)14F18H0447 (14F18H0447), (01)10801902132960 (17)230531 (10)14F21E0293 (14F21E0293), (01)10801902132960 (17)230531 (10)14F21F0076 (14F21F0076), (01)10801902132960 (17)230731 (10)14F21F0253 (14F21F0253), (01)10801902132960 (17)230731 (10)14F21G0239 (14F21G0239), (01)10801902132960 (17)231031 (10)14F21J0114 (14F21J0114), (01)10801902132960 (17)230930 (10)14F21J0372 (14F21J0372), (01)10801902132960 (17)230930 (10)14F21K0052 (14F21K0052), (01)10801902132960 (17)231031 (10)14F21L0138 (14F21L0138), (01)10801902132960 (17)231031 (10)14F21L0139 (14F21L0139), (01)10801902132960 (17)231130 (10)14F21L0215 (14F21L0215), (01)10801902132960 (17)231130 (10)14F21L0216 (14F21L0216), (01)10801902132960 (17)231130 (10)14F21L0220 (14F21L0220), (01)10801902132960 (17)231130 (10)14F21M0014 (14F21M0014), (01)10801902196399 (17)240229 (10)14F22C0105 (14F22C0105), (01)10801902196399 (17)240229 (10)14F22C0106 (14F22C0106), (01)10801902196399 (17)240229 (10)14F22C0107 (14F22C0107), (01)10801902196399 (17)240229 (10)14F22C0108 (14F22C0108), (01)10801902196399 (17)240229 (10)14F22C0109 (14F22C0109), (01)10801902196399 (17)240229 (10)14F22C0110 (14F22C0110), (01)10801902196399 (17)240331 (10)14F22D0085 (14F22D0085), (01)10801902196399 (17)240331 (10)14F22D0086 (14F22D0086), (01)10801902196399 (17)240331 (10)14F22D0087 (14F22D0087), (01)10801902196399 (17)240430 (10)14F22E0114 (14F22E0114), (01)10801902196399 (17)240430 (10)14F22E0117 (14F22E0117), (01)10801902132960 (17)240531 (10)14F22F0008 (14F22F0008), (01)10801902196399 (17)240531 (10)14F22F0090 (14F22F0090), (01)10801902196399 (17)240630 (10)14F22G0124 (14F22G0124), (01)10801902196399 (17)240630 (10)14F22G0125 (14F22G0125), (01)10801902196399 (17)240831 (10)14F22H0345 (14F22H0345), (01)10801902196399 (17)240930 (10)14F22K0030 (14F22K0030), (01)10801902196399 (17)240930 (10)14F22K0159 (14F22K0159), (01)10801902196399 (17)241031 (10)14F22K0222 (14F22K0222), (01)10801902196399 (17)241031 (10)14F22L0072 (14F22L0072), (01)10801902196399 (17)241130 (10)14F22M0039 (14F22M0039), (01)10801902196399 (17)241130 (10)14F22M0040 (14F22M0040), (01)10801902196399 (17)241130 (10)14F22M0117 (14F22M0117), (01)10801902196399 (17)241130 (10)14F22M0118 (14F22M0118), (01)10801902196399 (17)241231 (10)14F23A0178 (14F23A0178), (01)10801902196399 (17)241231 (10)14F23A0310 (14F23A0310), (01)10801902196399 (17)241231 (10)14F23A0311 (14F23A0311), (01)10801902196399 (17)250228 (10)14F23B0326 (14F23B0326), (01)10801902196399 (17)250228 (10)14F23B0327 (14F23B0327); n. Product Code: EDC-00820-B. UDI (Batch Number): (01)10801902133066 (17)230531 (10)13F21E0851 (13F21E0851), (01)10801902133066 (17)230531 (10)13F21F0214 (13F21F0214), (01)10801902133066 (17)230531 (10)13F21F0524 (13F21F0524), (01)10801902133066 (17)230531 (10)13F21F1021 (13F21F1021), (01)10801902133066 (17)230630 (10)13F21G1201 (13F21G1201), (01)10801902133066 (17)230731 (10)13F21H0533 (13F21H0533), (01)10801902133066 (17)230731 (10)13F21H0824 (13F21H0824), (01)10801902133066 (17)230831 (10)13F21J0067 (13F21J0067), (01)10801902133066 (17)230831 (10)13F21J0597 (13F21J0597), (01)10801902133066 (17)230930 (10)13F21K0048 (13F21K0048), (01)10801902133066 (17)231031 (10)13F21L0427 (13F21L0427), (01)10801902133066 (17)231130 (10)13F21M0283 (13F21M0283), (01)10801902133066 (17)240131 (10)13F22A1064 (13F22A1064), (01)10801902133066 (17)240430 (10)13F22E0183 (13F22E0183), (01)10801902133066 (17)240630 (11)220718 (10)13F22G0461 (13F22G0461), (01)10801902133028 (17)241130 (11)230102 (10)13F22M0459 (13F22J0599), (01)10801902133066 (17)240930 (11)221028 (10)13F22K1046 (13F22K1046), (01)10801902133066 (17)241031 (11)22115 (10)13R22J0599 (13R22J0599), (01)10801902133066 (17)250228 (11)230308 (10)33F23B1066 (33F23B1066), (01)10801902133066 (17)250228 (11)230328 (10)33F23C0237 (33F23C0237), (01)10801902133066 (17)250331 (11)230404 (10)33F23C0974 (33F23C0974); o. Product Code: EDC-00822. UDI (Batch Number): (01)10801902132984 (17)230731 (10)14F21G0118 (14F21G0118), (01)10801902132984 (17)230731 (10)14F21H0188 (14F21H0188), (01)10801902132984 (17)231130 (10)14F21L0217 (14F21L0217), (01)10801902196405 (17)240331 (10)14F22D0102 (14F22D0102), (01)10801902196405 (17)241231 (10)14F23A0063 (14F23A0063), (01)10801902196405 (17)250131 (10)14F23B0128 (14F23B0128); p. Product Code: EDC-00822-B. UDI (Batch Number): (01)10801902133080 (17)230930 (10)13F21K0049 (13F21K0049), (01)10801902133080 (17)231031 (10)13F21L0020 (13F21L0020), (01)10801902133080 (17)240430 (10)13F22E0443 (13F22E0443), (01)10801902133080 (17)240831 (11)220924 (10)13F22J0463 (13F22J0463), (01)10801902133080 (17)240930 (11)221021 (10)13F22K0572 (13F22K0572), (01)10801902133080 (17)241031 (11)221115 (10)13F22L0388 (13F22L0388), (01)10801902133080 (17)240831 (11)220922 (10)13R22H0448 (13R22H0448)

Why it was recalled

Potential for catheter separation or leakage

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Arrow International/Teleflex sent customers an "URGENT MEDICAL DEVICE RECALL" letter, via FedEx, on 05/19/2023. Customers were instructed to check for affected products in inventory, immediately discontinue use and quarantine the products and complete and return the Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Should you require further information or support concerning this issue, please contact Customer Service via email, phone, or FAX using the details provided below. Customer Service hours of operation are 8am 7pm EST. Contact: Customer Service Telephone: 1-866-396-2111 FAX: 1-855-419-8507 Email: Recalls@teleflex.com If you have any questions, please contact your local Teleflex sales representative or Teleflex Customer Service.

Recalling firm

Firm

ARROW INTERNATIONAL Inc.

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

Nationwide distribution. International distribution to Canada.

Timeline

Recall initiated

2023-05-19

Posted by FDA

2023-06-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.