Medline Medical Device Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
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 sterile medical devices where calibration issues have potential to compromise sterility assurance level, posing a risk of infection or harm if devices are not properly sterilized. No reported illnesses or injuries are stated, but the hazard is significant for high-risk medical equipment.
Plain-English summary
Medline Industries, LP is recalling approximately 207,196 units of multiple Medline Convenience Kit medical devices, including models such as Drawer 6-IV Fluids Gloves, Drawer 5, Neuro Cart drawers, Suction Tray, and Malignant Hyperthermia Cart, distributed nationwide.
The recall is due to calibration issues identified in the equipment used to sterilize and package these devices. Although all products were exposed to the validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the affected products.
Affected models include a wide range of medical convenience kits with multiple lot numbers. Healthcare facilities and individuals who have received these devices should contact Medline Industries, LP for instructions on replacement or return of affected units. A complete list of affected model numbers and lot numbers is available from the FDA's recall database.
The recalled product
- Product
- See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CAR
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- sterility-assurance
- 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) ACC010326
- UDI-DI: 10889942735525(each)
- 40889942735526(case)
- Lot Number: 21CDB175
- 2) ACC010326
- Lot Number: 21CDB692
- 3) ACC010326
- Lot Number: 21LDA438
- 4) ACC010326
- Lot Number: 22BDB172
- 5) ACC010326
- Lot Number: 22HDA973
- 6) ACC010326
- Lot Number: 23ADA426
- 7) ACC010326
- Lot Number: 23BDA230
- 8) ACC010326
- Lot Number: 23CDC052
- 9) ACC010326A
- UDI-DI: 10195327347147(each)
Distribution
Distributed nationwide across the United States.