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

Recall Z-2086-2023 — Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X

U.S. FDA — Device Enforcement · United States · 2023-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2086-2023
Date of alert
2023-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DeRoyal Industries Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50749756864676
Reported risk: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
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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