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

Recall Z-1122-2019 — BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

U.S. FDA — Device Enforcement · United States · 2019-03-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1122-2019
Date of alert
2019-03-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Company
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
18041501
Reported risk: The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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