ENT Surgical Kits Recalled for Potential Sterility Loss
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with potential sterility breach. The hazard is real but no illnesses, injuries, or deaths have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling the HENRY SCHEIN ENT SET UP PACK, Item No. 570-2742, a medical and surgical procedure kit. The recall affects kit serial/lot number 22252489778 that were distributed nationwide in the United States and in Canada.
During manufacturing, the outer bag of the kit may not have been completely sealed. An incomplete seal can result in a breach of the kit's sterility, which is critical for surgical and medical procedures where sterile conditions are required to prevent infection and contamination.
Consumers and healthcare facilities that have received affected kits should stop use immediately and contact their supplier or Stradis Medical. No illnesses or injuries have been reported to date.
The recalled product
- Product
- HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- incomplete-sealing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI (case) H65857027421
- UDI/DI (kit)M75257027420
- Serial/Lot Numbers: 22252489778
Distribution
Distributed nationwide across the United States.
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