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

Recall Z-0737-2021 — Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE,

U.S. FDA — Device Enforcement · United States · 2020-11-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0737-2021
Date of alert
2020-11-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ROi CPS LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
800221010
Reported risk: Gauze sponges contained in custom kits may be flaking or fraying.
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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