Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.
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 3/5 (High).
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: The recall is classified as FDA Class II and involves a potential loss of sterility, which represents a high-risk hazard where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling certain Medline Convenience Kits, specifically the CHEST/BREAST-LF (Model Number: DYNJ83950). The recall involves 150 units across multiple lot numbers.
The company identified calibration issues with the equipment used for sterilization and packaging. While all products underwent validated sterilization and packaging cycles, these calibration issues may impact the sterility assurance level (SAL) of the affected devices.
This recall is distributed nationwide within the United States and worldwide. Users should check their inventory for the affected lot numbers and follow manufacturer instructions regarding the use of these kits.
The recalled product
- Product
- Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 150
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) DYNJ83950
- UDI-DI: 10195327318925(each)
- 40195327318926(case)
- Lot Number: 24DBT832
- 2) DYNJ83950
- Lot Number: 24CBH626
- 3) DYNJ83950
- Lot Number: 23LBR075
- 4) DYNJ83950
- Lot Number: 23FBF248
- 5) DYNJ83950
- Lot Number: 23CBG610
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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