—#170840

Product

Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153

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 #170840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.