Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.
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 where injury has not yet been reported. Per rubric, risk-of-harm products without reported injury qualify as High severity.
Plain-English summary
Medline Industries, LP is recalling 779 units of Medline Convenience Kits and CPNB Setup Trays due to issues with calibration of the equipment used to sterilize and package the devices. The affected products include multiple model numbers: DYNJ56436A, DYNJ56436B, DYNJRA1979, DYNJRA1979A, and SAMPA0108.
All products were exposed to validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products. The recall affects products distributed worldwide, including throughout the United States.
Consumers should stop using the affected products immediately and contact Medline Industries for a replacement or refund. Healthcare facilities should quarantine the products and await further instructions from the company.
The recalled product
- Product
- Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
- Manufacturer
- Medline Industries, LP
- Affected units
- 779
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) DYNJ56436A
- UDI-DI: 10889942749874(each)
- 40889942749875(case)
- Lot Number: 21BMC737
- 2) DYNJ56436A
- Lot Number: 21AMB799
- 3) DYNJ56436B
- UDI-DI: 10193489869569(each)
- 40193489869560(case)
- Lot Number: 21DME244
- 4) DYNJRA1979
- UDI-DI: 10195327186852(each)
- 40195327186853(case)
- Lot Number: 22IBU628
- 5) DYNJRA1979
- Lot Number: 22GBV936
- 6) DYNJRA1979A
- UDI-DI: 10195327649258(each)
- 40195327649259(case)
- Lot Number: 25DME153
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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