Medline Medical Device Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. 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: FDA Class II recall with theoretical risk to sterility assurance level. No illnesses or injuries reported, but medical device sterility issues pose potential for harm if devices are not sterile when used.
Plain-English summary
Medline Industries, LP is recalling 154,427 units of Medline Convenience Kits due to issues with calibration of equipment used to sterilize and package the devices. The affected products include various drawer kits, neuro cart kits, transplant kits, procedure kits, and other medical device organization systems identified by multiple model numbers and lot numbers.
The recall affects products distributed worldwide, including throughout the United States. While all products were exposed to validated sterilization and packaging cycles, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities should stop using the affected products and contact Medline Industries for replacement or refund. Patients should contact their healthcare providers if they have concerns about potential exposure. No illnesses or injuries have been reported in connection with these products.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
- Manufacturer
- Medline Industries, LP
- Affected units
- 154,427
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: 22HDA973
- 2) ACC010326
- Lot Number: 22BDB172
- 3) ACC010326
- Lot Number: 21LDA438
- 4) ACC010326
- Lot Number: 21CDB692
- 5) ACC010326
- Lot Number: 21CDB175
- 6) ACC010326A
- UDI-DI: 10195327347147(each)
- 40195327347148(case)
- Lot Number: 24GDA256
- 7) ACC010326A
- Lot Number: 23IDB293
- 8) ACC010475
- UDI-DI: 10193489469011(each)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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