—#210796

Product

MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072

FDA product code: OFR — Tracheobronchial Suction Catheter Kit
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 1) REF CDS983184I, UDI/DI 10195327178352 (each) 40195327178353 (case), Lot Numbers: 22LBB795, 23FBJ754, 23BBH106, 23CBT619, 23HBY087, 23HBP974, 23KBI669, 23LBD939, 23KBM394; 2) REF CDS983466L, UDI/DI 10195327497217 (each) 40195327497218 (case), Lot Numbers: 23JDB850, 23IDB539, 23KDB596, 24DDB278, 24DDA871, 24BDA878, 24ADA819, 24CDB315; 3) REF CDS983486K, UDI/DI 10195327497200 (each) 40195327497201 (case), Lot Numbers: 23JDA349, 24CDA873, 24ADA731, 24ADB821; 4) REF CDS984259N, UDI/DI 10193489862232 (each) 40193489862233 (case), Lot Numbers: 22KBJ788, 22JBH993, 22JBH284, 22LBB413; 5) REF CDS984259O, UDI/DI 10195327297817 (each) 40195327297818 (case), Lot Numbers: 23ABM783, 23ABK571; 6) REF CDS984282L, UDI/DI 10195327438920 (each) 40195327438921 (case), Lot Numbers: 23LMA461; 7) REF CDS984895I, UDI/DI 10193489983814 (each) 40193489983815 (case), Lot Numbers: 22FBL382, 22KBD792, 23DBM334, 23ABM451, 23FBK273; 8) REF CDS984895J, UDI/DI 10195327469092 (each) 40195327469093 (case), Lot Numbers: 23KBH104, 23KBH045; 9) REF CDS984895K, UDI/DI 10195327620875 (each) 40195327620876 (case), Lot Numbers: 24BBQ203, 24CBM385; 10) REF DYNJ0101206D, UDI/DI 10195327028855 (each) 40195327028856 (case), Lot Numbers: 22EMG943, 22GMB620; 11) REF DYNJ0101206F, UDI/DI 10195327269470 (each) 40195327269471 (case), Lot Numbers: 22KMB120, 22KMB121, 23EMB091, 23DMB727, 23BMD165, 23FMD066, 23GMH580, 23JMA281, 23KBV062, 24ABN126, 24DBT379, 24DBD204; 12) REF DYNJ0101314D, UDI/DI 10195327286453 (each) 40195327286454 (case), Lot Numbers: 23HDA133, 23FDA245; 13) REF DYNJ0101397M, UDI/DI 10195327295813 (each) 40195327295814 (case), Lot Numbers: 22LBL740; 14) REF DYNJ0101397N, UDI/DI 10195327332952 (each) 40195327332953 (case), Lot Numbers: 23ABU509, 23FBJ127, 23CBT405, 23IBK582; 15) REF DYNJ0131777I, UDI/DI 10195327124755 (each) 40195327124756 (case), Lot Numbers: 22FMH017; 16) REF DYNJ0131777J, UDI/DI 10195327216627 (each) 40195327216628 (case), Lot Numbers: 22GMH364; 17) REF DYNJ0131777K, UDI/DI 10195327248031 (each) 40195327248032 (case), Lot Numbers: 23BMC153, 22JMF782, 22LMB801, 23CME007; 18) REF DYNJ0131777L, UDI/DI 10195327416065 (each) 40195327416066 (case), Lot Numbers: 23IMA466, 23GMI881, 23IMG022, 23LMA388, 23KMB800, 23FMI119, 24AMI064, 24CMA472; 19) REF DYNJ0160700F, UDI/DI 10195327304294 (each) 40195327304295 (case), Lot Numbers: 22LDC085, 23DDB405; 20) REF DYNJ0161710G, UDI/DI 10195327304300 (each) 40195327304301 (case), Lot Numbers: 23BDA563, 23ADB489; 21) REF DYNJ0161710I, UDI/DI 10195327375003 (each) 40195327375004 (case), Lot Numbers: 23DDB344, 23DDA346; 22) REF DYNJ02462L, UDI/DI 10195327269975 (each) 40195327269976 (case), Lot Numbers: 23HMB171; 23) REF DYNJ02463J, UDI/DI 10195327291112 (each) 40195327291113 (case), Lot Numbers: 23IMI445, 23JMJ897; 24) REF DYNJ0387711F, UDI/DI 10198459005893 (each) 40198459005894 (case), Lot Numbers: 24FMI719; 25) REF DYNJ0429404O, UDI/DI 10195327050092 (each) 40195327050093 (case), Lot Numbers: 22EMH911, 22HMD262, 22KMD325, 23CMH759, 23CMC034; 26) REF DYNJ0451506P, UDI/DI 10195327046033 (each) 40195327046034 (case), Lot Numbers: 22FBD904, 22IBG229, 22KBJ001, 22KBF361, 22FBJ383, 23CBA965, 23CBC262, 23HBP907, 23FBJ832, 23KBJ579, 23IBW132; 27) REF DYNJ0774664K, UDI/DI 10195327045999 (each) 40195327045990 (case), Lot Numbers: 23FBV288, 23FBD634, 23IBP555; 28) REF DYNJ0826705N, UDI/DI 10193489265682 (each) 40193489265683 (case), Lot Numbers: 22GMA868, 23EMI243, 23KMJ016; 29) REF DYNJ0843898I, UDI/DI 10195327288693 (each) 40195327288694 (case), Lot Numbers: 23DDB257, 23ADB839, 23GDA828, 23IDC126; 30) REF DYNJ21948S, UDI/DI 10195327104726 (each) 40195327104727 (case), Lot Numbers: 22JBB180, 22JBC021; 31) REF DYNJ27320V, UDI/DI 10195327104719 (each) 40195327104710 (case), Lot Numbers: 22DBE423, 22DBS049, 22JBH705, 22DBB586, 23EBE794, 22LBQ654, 22DBS054, 23CBL338, 23FBO863; 32) REF DYNJ33585F, UDI/DI 10195327469528 (each) 40195327469529 (case), Lot Numbers: 23HDB160, 23JDA407; 33) REF DYNJ37531G, UDI/DI 10195327497224 (each) 40195327497225 (case), Lot Numbers: 23IDC199, 24DDA059; 34) REF DYNJ43111G, UDI/DI 10195327007614 (each) 40195327007615 (case), Lot Numbers: 22EBK964, 22DBM378, 23ABD640, 22JBK014, 23FBR570, 23GBW466, 23JBS323, 23KBV859, 24BBA668, 24CBH236; 35) REF DYNJ43776G, UDI/DI 10193489989717 (each) 40193489989718 (case), Lot Numbers: 22GBK302, 22JBD640, 23BBA747, 23GBN842, 22JBG530, 23GBS093, 23JBT523, 24ABR379, 24CBD054, 24EBE400; 36) REF DYNJ44170G, UDI/DI 10195327413040 (each) 40195327413041 (case), Lot Numbers: 23KBF904; 37) REF DYNJ44982J, UDI/DI 10195327381080 (each) 40195327381081 (case), Lot Numbers: 23HBH626, 23FBE306; 38) REF DYNJ45576B, UDI/DI 10195327059200 (each) 40195327059201 (case), Lot Numbers: 23DBJ589, 23DBB974, 22JBD150, 22IBS180, 23GBP473, 23IBI793, 23JBS988, 23GBA243, 23FBF257; 39) REF DYNJ48370C, UDI/DI 10195327491635 (each) 40195327491636 (case), Lot Numbers: 23IBK589, 23JBH535; 40) REF DYNJ52419J, UDI/DI 10195327222703 (each) 40195327222704 (case), Lot Numbers: 22HDB178; 41) REF DYNJ52419K, UDI/DI 10195327339265 (each) 40195327339266 (case), Lot Numbers: 23DDB020, 23BDC171, 23HDB272, 23FDC083; 42) REF DYNJ52426J, UDI/DI 10195327339333 (each) 40195327339334 (case), Lot Numbers: 23DDB127, 23HDB256, 23FDA419; 43) REF DYNJ52758G, UDI/DI 10195327409685 (each) 40195327409686 (case), Lot Numbers: 23HBE646, 23EBU553, 23JBE363; 44) REF DYNJ53648B, UDI/DI 10195327012083 (each) 40195327012084 (case), Lot Numbers: 22GBH903, 23GBQ991, 24DBT986, 23ABJ120, 23EBB251, 23GBS479; 45) REF DYNJ56995C, UDI/DI 10195327103415 (each) 40195327103416 (case), Lot Numbers: 22EBQ045, 22GBM277; 46) REF DYNJ60922F, UDI/DI 10195327470265 (each) 40195327470266 (case), Lot Numbers: 23IBK275; 47) REF DYNJ61309B, UDI/DI 10195327155735 (each) 40195327155736 (case), Lot Numbers: 22EMC922, 22LMD294, 23JBV869; 48) REF DYNJ62032B, UDI/DI 10195327058289 (each) 40195327058280 (case), Lot Numbers: 22FBP870, 22KBG692, 23BBD433, 23EBR621, 23IBK599, 23GBM365; 49) REF DYNJ62649A, UDI/DI 10195327109912 (each) 40195327109913 (case), Lot Numbers: 22GDA925, 22EDB879, 22KDB262, 22JDA165, 22KDB900; 50) REF DYNJ63315B, UDI/DI 10193489958102 (each) 40193489958103 (case), Lot Numbers: 22FBY596, 22FBR138; 51) REF DYNJ63332F, UDI/DI 10195327270773 (each) 40195327270774 (case), Lot Numbers: 23HMF316; 52) REF DYNJ63333B, UDI/DI 10193489986877 (each) 40193489986878 (case), Lot Numbers: 22EBV290, 22DBV017; 53) REF DYNJ63333C, UDI/DI 10195327270018 (each) 40195327270019 (case), Lot Numbers: 23GMC984, 23AMI108, 23FMG683, 23IMG360; 54) REF DYNJ63334C, UDI/DI 10195327041243 (each) 40195327041244 (case), Lot Numbers: 22DBN552; 55) REF DYNJ63334D, UDI/DI 10195327275679 (each) 40195327275670 (case), Lot Numbers: 22LME564, 23BMB162, 23HMF139, 23JMG131; 56) REF DYNJ63336B, UDI/DI 10193489943740 (each) 40193489943741 (case), Lot Numbers: 22FBR970; 57) REF DYNJ63336C, UDI/DI 10195327273422 (each) 40195327273423 (case), Lot Numbers: 23AMA553, 23IMG718, 23HMF616, 23KMF634, 23JMA204, 23IMD286; 58) REF DYNJ63625C, UDI/DI 10195327350390 (each) 40195327350391 (case), Lot Numbers: 23CBT772, 23JBA948, 23EBU585, 23IBB697, 23JBO841; 59) REF DYNJ63890A, UDI/DI 10195327221843 (each) 40195327221844 (case), Lot Numbers: 22JDC115, 23GDB230, 23BDA782, 23JDB416, 23KDB075, 23CDC581, 23IDA389, 24DDB748; 60) REF DYNJ64235B, UDI/DI 10193489382662 (each) 40193489382663 (case), Lot Numbers: 22GMI068, 23CMD690; 61) REF DYNJ65487B, UDI/DI 10195327303662 (each) 40195327303663 (case), Lot Numbers: 23ABN443, 23CBM523, 23IBM894; 62) REF DYNJ67401B, UDI/DI 10195327353001 (each) 40195327353002 (case), Lot Numbers: 23CMG483, 23DMD152, 23KMH872; 63) REF DYNJ67754B, UDI/DI 10195327227982 (each) 40195327227983 (case), Lot Numbers: 22HBR985, 22HBT613, 22JBX075, 22LBJ260, 23BBS826, 23DBC526; 64) REF DYNJ67985B, UDI/DI 10195327022679 (each) 40195327022670 (case), Lot Numbers: 22EMG226; 65) REF DYNJ67985C, UDI/DI 10195327270407 (each) 40195327270408 (case), Lot Numbers: 23KMJ096; 66) REF DYNJ68211B, UDI/DI 10195327352493 (each) 40195327352494 (case), Lot Numbers: 23FMF614; 67) REF DYNJ69587B, UDI/DI 10195327372354 (each) 40195327372355 (case), Lot Numbers: 23HMC907, 24DMA249; 68) REF DYNJ82172, UDI/DI 10195327182601 (each) 40195327182602 (case), Lot Numbers: 23FDA365; 69) REF DYNJ82175, UDI/DI 10195327182618 (each) 40195327182619 (case), Lot Numbers: 23HDB289; 70) REF DYNJ82175B, UDI/DI 10195327534929 (each) 40195327534920 (case), Lot Numbers: 23JMG205; 71) REF DYNJ82177, UDI/DI 10195327182656 (each) 40195327182657 (case), Lot Numbers: 23FDC242; 72) REF DYNJ82177B, UDI/DI 10195327534936 (each) 40195327534937 (case), Lot Numbers: 23KMC523; 73) REF DYNJ82194, UDI/DI 10195327183486 (each) 40195327183487 (case), Lot Numbers: 23FDC244; 74) REF DYNJ82285, UDI/DI 10195327179045 (each) 40195327179046 (case), Lot Numbers: 23IMC659; 75) REF DYNJ82654A, UDI/DI 10195327489649 (each) 40195327489640 (case), Lot Numbers: 23KBF180, 23IBU511, 23HBT084; 76) REF DYNJ82654B, UDI/DI 10195327557690 (each) 40195327557691 (case), Lot Numbers: 23LBJ944, 24ABW630, 24DBT628, 24CBV286; 77) REF DYNJ82656C, UDI/DI 10195327489656 (each) 40195327489657 (case), Lot Numbers: 23IBR904; 78) REF DYNJ82657A, UDI/DI 10195327489663 (each) 40195327489664 (case), Lot Numbers: 23IBS673; 79) REF DYNJ82657B, UDI/DI 10195327557782 (each) 40195327557783 (case), Lot Numbers: 24ABK113, 24BBP749, 24DBF082, 24DBQ952; 80) REF DYNJ901073G, UDI/DI 10193489944600 (each) 40193489944601 (case), Lot Numbers: 22EMH483, 22IMF369, 22HMI055, 22HMC726, 22GMI088, 22GME976, 22KMA663, 22IMF609, 22GMB443; 81) REF DYNJ901073I, UDI/DI 10195327232504 (each) 40195327232505 (case), Lot Numbers: 22KMC464, 23BMB966, 23AMF537, 23AME484; 82) REF DYNJ901801K, UDI/DI 10195327495534 (each) 40195327495535 (case), Lot Numbers: 24CDA462, 23JDC094, 24ADA394; 83) REF DYNJ902116I, UDI/DI 10195327497422 (each) 40195327497423 (case), Lot Numbers: 23JDB483, 23KDB475, 24ADA959, 24CDB867; 84) REF DYNJ902126I, UDI/DI 10195327497231 (each) 40195327497232 (case), Lot Numbers: 23LDA136, 24BDB428, 24ADA164; 85) REF DYNJ902258J, UDI/DI 10195327497477 (each) 40195327497478 (case), Lot Numbers: 24ADA255, 24ADA820, 24BDB764; 86) REF DYNJ902508I, UDI/DI 10195327336677 (each) 40195327336678 (case), Lot Numbers: 23EBR103; 87) REF DYNJ903810C, UDI/DI 10193489274134 (each) 40193489274135 (case), Lot Numbers: 22JBR487, 23IBG239, 23HBO191, 23KBC866, 23EBP263, 24ABA510, 24BBV513, 24BBE242; 88) REF DYNJ904491J, UDI/DI 10195327157517 (each) 40195327157518 (case), Lot Numbers: 22EBU208; 89) REF DYNJ904491K, UDI/DI 10195327186333 (each) 40195327186334 (case), Lot Numbers: 23ABV356; 90) REF DYNJ904558F, UDI/DI 10195327497378 (each) 40195327497379 (case), Lot Numbers: 24DDC043; 91) REF DYNJ906052B, UDI/DI 10195327010164 (each) 40195327010165 (case), Lot Numbers: 22IBA880, 23CBG753, 23BBL154, 23DBF038; 92) REF DYNJ906655F, UDI/DI 10193489993998 (each) 40193489993999 (case), Lot Numbers: 22JDC012, 22IDB318, 22GDB705, 22LDA295; 93) REF DYNJ906655G, UDI/DI 10195327301835 (each) 40195327301836 (case), Lot Numbers: 23GDB026, 23HDC613, 23EDB087, 23FDA004; 94) REF DYNJ906901A, UDI/DI 10195327303358 (each) 40195327303359 (case), Lot Numbers: 23ABE779, 23FBP600, 23HBS841; 95) REF DYNJ906948B, UDI/DI 10195327380991 (each) 40195327380992 (case), Lot Numbers: 23EBD951, 23LBE795, 23HBI581, 23EBN930, 23HBY101, 23GBS824; 96) REF DYNJ906948C, UDI/DI 10195327567156 (each) 40195327567157 (case), Lot Numbers: 24ABQ831, 24CBD478, 24DBD740, 24DBN334; 97) REF DYNJ907206F, UDI/DI 10195327600907 (each) 40195327600908 (case), Lot Numbers: 24BBL775, 24DBM144; 98) REF DYNJ907393C, UDI/DI 10195327359133 (each) 40195327359134 (case), Lot Numbers: 23EMD891; 99) REF DYNJ907393D, UDI/DI 10195327462345 (each) 40195327462346 (case), Lot Numbers: 23IMG307; 100) REF DYNJ907411A, UDI/DI 10195327335748 (each) 40195327335749 (case), Lot Numbers: 23GMC938; 101) REF DYNJ907577, UDI/DI 10193489437713 (each) 40193489437714 (case), Lot Numbers: 22GBH331, 22HBS399, 23IBO496, 23CBW088; 102) REF DYNJVB91072, UDI/DI 10193489801156 (each) 40193489801157 (case), Lot Numbers: 22ILA262, 22HLA486

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-10-09
Posted by FDA: 2024-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.