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

Recall Z-2464-2014 — MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE% ECONOMY 53" X 77" (1) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET EXTREMITY ABS 125" X 85"

U.S. FDA — Device Enforcement · United States · 2014-05-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2464-2014
Date of alert
2014-05-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Customed, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
112104281
Reported risk: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
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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