Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal
A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in 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: The recalled surgical kit presents a risk of harm through potential sterility compromise (incompletely sealed bag may result in sterility breach). No illnesses or injuries have been reported, which per the rubric qualifies this as High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Henry Schein Vas Reversal Pack, a surgical procedure kit, is being recalled because manufacturing conditions may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
The recall affects Henry Schein Vas Reversal Packs (Item No. 888-2549) with UDI/DI case code H65888825491, UDI/DI kit code M75288825490, and lot number 22230489459. The affected kits were distributed nationwide in the United States and in Canada.
Consumers who have received affected kits should stop use and contact Stradis Medical, LLC dba Stradis Healthcare for instructions on replacement or return.
The recalled product
- Product
- HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- Hazard
- sterility-breach
- incomplete-seal
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) H65888825491
- UDI/DI (kit)M75288825490
- Serial/Lot Numbers: 22230489459
Distribution
Distributed nationwide across the United States.
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