Surgical packs (includes trays, bags and kits) Used by medical staff… — recall Z-0237-2015
U.S. FDA — Device Enforcement · United States · 2014-10-08 · Class I
As described by U.S. FDA — Device Enforcement: Surgical packs (includes trays, bags and kits) Used by medical staff to perform 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 →
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Distribution to Florida, New York and Puerto Rico..
Reported risk: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
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