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

Recall Z-2495-2014 — Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLEAR (6) TOWEL CLOTH

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-2495-2014
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)
112093710
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.