Medline Surgical Convenience Kits Recalled for Sterilization Calibration Issues
Medline Industries is recalling 114,778 surgical convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products. No illnesses or injuries have been reported.
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 involving medical devices used in surgical procedures. The hazard—potential loss of sterility assurance—could create risk of serious infection or contamination, and no illnesses have been reported yet, making this a high-risk situation without reported adverse outcomes.
Plain-English summary
Medline Industries, LP is recalling multiple surgical convenience kits, including Major Laparotomy, Minor Laparotomy, and Lap Gastric Bypass models, distributed nationwide and worldwide. The recall affects 114,778 units across numerous lot numbers and model variations.
Medline identified issues related to calibration of equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Patients and healthcare providers who have received these kits should contact their healthcare facility or Medline for guidance on next steps. The FDA classification for this recall is Class II. For a complete list of affected model numbers and lot numbers, consult the FDA's official recall notice.
The recalled product
- Product
- See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS
- Manufacturer
- Medline Industries, LP
- Hazard
- sterility-assurance
- sterilization-equipment-calibration
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 (20)
- 1) CDS860015U
- UDI-DI: 10193489847994(each)
- 40193489847995(case)
- Lot Number: 21FBR386
- 2) CDS860015U
- Lot Number: 21GBS688
- 3) CDS860015U
- Lot Number: 21IBL031
- 4) CDS860015U
- Lot Number: 21KBB595
- 5) CDS860015U
- Lot Number: 21LBD726
- 6) CDS860015U
- Lot Number: 21LBT172
- 7) CDS860015V
- UDI-DI: 10195327209582(each)
- 40195327209583(case)
- Lot Number: 22HBF170
- 8) CDS860015W
- UDI-DI: 10195327349509(each)
Distribution
Distributed nationwide across the United States.