Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2670-2020 — PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398)

U.S. FDA — Device Enforcement · United States · 2020-06-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2670-2020
Date of alert
2020-06-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Company
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741047329
Reported risk: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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