Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide 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: This is an FDA Class II recall of surgical kits with potential sterility compromise. The hazard is stated as theoretical ('may result'), and no illnesses or injuries are mentioned in the recall notice, fitting the rubric criteria for High (3): risk-of-harm product without reported injury.
Plain-English summary
Stradis Healthcare, operating as Stradis Medical, LLC, is recalling Henry Schein Major Extremity surgical procedure kits (Item No. 570-2783) distributed nationwide in the US and Canada. Certain units may have incomplete outer bag sealing, which could result in a breach in the kit's sterility.
Healthcare facilities and medical professionals should discontinue use of affected kits. Recalled kits are identified by Item No. 570-2783, with UDI/DI (case) H65857027831, UDI/DI (kit) M75257027830, and Lot Number 22234489305. Those with affected kits should contact Stradis Healthcare for recall instructions.
The integrity of the sterile barrier in surgical kits is essential to patient safety.
The recalled product
- Product
- HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 5
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) H65857027831
- UDI/DI (kit)M75257027830
- Serial/Lot Numbers: 22234489305
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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