Surgical Procedure Trays Recalled for Potential Sterility Breach
Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.
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: This is an FDA Class II medical device recall involving a manufacturing defect that affects the sterility assurance of surgical procedure trays, which are risk-of-harm products. No adverse events or illnesses have been reported, placing this in the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Henry Schein Basin Pack surgical procedure trays and kits (Item No. 570-1692) due to a manufacturing defect. The outer packaging of these sterile kits may be incompletely sealed.
An incomplete seal on the outer bag may result in a breach of the kit's sterility, which could compromise the sterile condition necessary for safe use during medical and surgical procedures.
The affected product was distributed in the United States and Canada. The recalled lot number is 22257490755.
Consumers and healthcare providers with this product should discontinue use and contact the manufacturer for instructions regarding return or replacement.
The recalled product
- Product
- HENRY SCHEIN, Basin Pack, Item No.570-1692
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- Affected units
- 30
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) H65857016921
- UDI/DI (kit)M75257016920
- Serial/Lot Numbers: 22257490755
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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