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

Recall Z-1963-2020 — DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. Port Pack Pgybk, 89-8

U.S. FDA — Device Enforcement · United States · 2020-04-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1963-2020
Date of alert
2020-04-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DeRoyal Industries Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
49935860
Reported risk: DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
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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