Surgical kit recall due to outer bag perforation and sterility risk
Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.
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 a surgical kit with risk of sterility compromise due to outer bag integrity failure. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the Coryell Memorial Hospital Total Joint Pack Surgical Kit (SKU 690-260, UDI M7526902600). The recall affects 348 units distributed nationwide in Indiana, Texas, and Pennsylvania.
The outer bag of the surgical kit may be perforated or torn, which could result in a breach of the kit's sterility. A compromised sterile barrier could allow contamination of surgical instruments or components before use.
Healthcare facilities that have received this product should stop use immediately and check inventory against the affected lot numbers. No illnesses or injuries have been reported related to this recall. Affected lot numbers include: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, and 21270476822.
The recalled product
- Product
- Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- Hazard
- sterility-breach
- contamination
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 (19)
- SKU/Part Number 690-260
- UDI M7526902600 Lot Numbers: 1912331779
- 1914333072
- 1915433813
- 1915634371
- 1919334769
- 1923436351
- 1930338689
- 1935342884
- 2006644326
- 2007745836
- 20149461110
- 20241463865
- 20303466242
- 20328467437
- 20356468152
- 21033468960
- 21050471039
- 21270476822
Distribution
Distributed nationwide across the United States.
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