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

ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WfTAPE SPLIT (1) SHEET EXTREMITY ABS. 125" X 85" (1) GOWN SOFT SMS STD. XLGE SET IN SLEEVE (1 — recall Z-2452-2014

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-2452-2014
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): 112010142

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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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