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

Recall Z-2492-2014 — Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (

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-2492-2014
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): 112062218

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.

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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