Medline Burn Care Kits Recalled Over Sterilization Calibration Issues
Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices where sterility assurance may be compromised, which falls under the rubric criterion for FDA Class II recalls with potential for significant health consequences.
Plain-English summary
Medline Industries, LP is recalling 291 units of three Medline Convenience Kits: BURN PACK (Model DYNJ15668R), BURN PACK-LF (Model DYNJ42829B), and BURN CARE PACK-LF (Model DJT3437). The recall affects products distributed worldwide, including US nationwide distribution.
The recall is being issued because Medline identified issues related to calibration of the equipment used to sterilize and package the devices. While all products were exposed to the 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 and consumers who received or purchased the recalled products should immediately check the lot numbers and UDI-DI codes listed in the recall notice. The affected lot numbers are 23HMB037, 22IBI084, and 25FBK633.
Consumers should contact Medline Industries, LP for instructions on returning or replacing the affected products. Healthcare providers should use alternative products if available and consult with their infection control teams regarding patient care decisions.
The recalled product
- Product
- Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Burn Care Kits
- Affected units
- 291
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 (12)
- 1) DYNJ15668R
- UDI-DI: 10195327108502(each)
- 40195327108503(case)
- Lot Number: 23HMB037
- 2) DYNJ42829B
- UDI-DI: 10193489880151(each)
- 40193489880152(case)
- Lot Number: 22IBI084
- 3) DYNJT3437
- UDI-DI: 10198459325076(each)
- 40198459325077(case)
- Lot Number: 25FBK633
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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