General closure kits recalled over sterilization equipment calibration issues
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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: Scored 3 under the risk-of-harm criterion: the firm states the calibration issues have the potential to impact the sterility assurance level of products used in sterile procedures, and no injuries are reported.
Plain-English summary
Medline convenience kits are being recalled by Medline Industries, LP, covering the Kit General Closure under model number DYKMBNDL200A.
The record states Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. It states all products were exposed to the 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 record lists 108 units, with model numbers, UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A sterility assurance level that cannot be relied on carries an infection risk for products used in sterile procedures. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medline's instructions.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- 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: 25HBD027
- 2) DYKMBNDL200A
- Lot Number: 25FBD161
- 3) DYKMBNDL200A
- Lot Number: 25EBN454
- 4) DYKMBNDL200A
- Lot Number: 25EBG142
- 5) DYKMBNDL200A
- Lot Number: 25EBE995
- 6) DYKMBNDL200A
- Lot Number: 25DBE771
- 7) DYKMBNDL200A
- Lot Number: 25CBB549
- 8) DYKMBNDL200A
- Lot Number: 25BBS071
- 9) DYKMBNDL200A
- Lot Number: 25BBB895
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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