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

Recall Z-2486-2014 — Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77" STD SMS (1) DRAPE

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-2486-2014
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)
112104283
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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