Medline Convenience Kits General Closure sterilization calibration issue
Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.
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: FDA Class II medical device recall with a risk-of-harm hazard (compromised sterility of medical devices) where no reported adverse events or illnesses are mentioned in the source text. Per the rubric, this matches the criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, Model DYKMBNDL200A, distributed nationwide. The recall affects 108 units across 14 different lot numbers due to identified calibration issues with equipment used to sterilize and package the devices.
Although 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 affected products. This means the devices may not meet intended sterility standards.
Patients and healthcare facilities that have received these kits should discontinue use and contact Medline Industries with any questions or concerns about the recalled products.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
- Manufacturer
- Medline Industries, LP
- Affected units
- 108
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) DYKMBNDL200A
- UDI-DI: 10195327240592(each)
- 40195327240593(case)
- Lot Number: 22KBD675
- 2) DYKMBNDL200A
- Lot Number: 23KBA331
- 3) DYKMBNDL200A
- Lot Number: 24ABH890
- 4) DYKMBNDL200A
- Lot Number: 24CBK339
- 5) DYKMBNDL200A
- Lot Number: 24FBK537
- 6) DYKMBNDL200A
- Lot Number: 25BBB895
- 7) DYKMBNDL200A
- Lot Number: 25BBS071
- 8) DYKMBNDL200A
- Lot Number: 25CBB549
- 9) DYKMBNDL200A
- Lot Number: 25DBE771
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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