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

Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff… — recall Z-1417-2016

U.S. FDA — Device Enforcement · United States · 2016-01-07 · Class II

As described by U.S. FDA — Device Enforcement: Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1417-2016
Date of alert
2016-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Customed, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed only in Puerto Rico.
Reported risk: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.