—#170841

Product

Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Lot Numbers: US: 71F15J1055 71F15K0223 71F15D1461 71F18A1856 Worldwide: 71F14H0908 71F15K0223 71F16M1878 71F18A0343 71F14J0958 71F15L0155 71F17A0524 71F18A1856 71F14J1954 71F15L1514 71F17A1118 71F18B0295 71F14J1955 71F15M0771 71F17A1119 71F18B3053 71F14K1117 71F16A0286 71F17A2452 71F18C0752 71F14L0040 71F16A1142 71F17C0184 71F18C1686 71F14L0813 71F16B0097 71F17C0408 71F18C2250 71F14M0892 71F16B1126 71F17C2294 71F18C3030 71F14M1389 71F16B2212 71F17C2749 71F18C3042 71F15A0039 71F16C1127 71F17D0329 71F18D2222 71F15D1461 71F16D1063 71F17E1237 71F18E1357 71F15E1320 71F16E0976 71F17E2316 71F18E1753 71F15F1005 71F16F0403 71F17F0829 71F18F2625 71F15F1955 71F16F1512 71F17G1171 71F18G0263 71F15G0461 71F16G0246 71F17G1628 71F18G2183 71F15G1764 71F16H0027 71F17H2043 71F18H0650 71F15H0569 71F16H0595 71F17J0668 71F18H1673 71F15H1347 71F16L0623 71F17L1848 71F18J0116 71F15J0063 71F16L1734 71F17M1416 71F15J1055 71F16M0795 71F17M1978

Why it was recalled

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Root cause (FDA determination)

Error in labeling

Action the firm took

Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: FL, NC

Timeline

Recall initiated: 2019-01-10
Terminated: 2020-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170841. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.