Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits 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 involves a potential loss of sterility in medical devices, which represents a high-risk hazard where injury has not yet been reported.
Plain-English summary
Medline Industries, LP has identified issues related to the calibration of equipment used to sterilize and package Medline Convenience Kits. These kits include the ANCILLARY PACK-LF (Model DYNJ0185290G) and the OPEN HEART ANESTHESIA ICC-A (Model DYNJ905567A).
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.
This recall affects 551 units distributed nationwide in the US. Users should check their inventory for the specific lot numbers listed in the official notice.
The recalled product
- Product
- Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Medical Kits
- Hazard
- Affected units
- 551
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) DYNJ0185290G
- UDI-DI: 10193489378054(each)
- 40193489378055(case)
- Lot Number: 22LBQ336
- 2) DYNJ905567A
- UDI-DI: 10193489348927(each)
- 40193489348928(case)
- Lot Number: 24BBN429
- 3) DYNJ905567A
- Lot Number: 23KBI089
- 4) DYNJ905567A
- Lot Number: 23HBG596
- 5) DYNJ905567A
- Lot Number: 23FBL644
- 6) DYNJ905567A
- Lot Number: 23FBG152
- 7) DYNJ905567A
- Lot Number: 23EBH550
- 8) DYNJ905567A
- Lot Number: 23CBQ546
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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