Medline Convenience Kits medical devices recalled due to sterilization calibration issues
Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.
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: This is an FDA Class II recall of sterile medical devices where a calibration defect could compromise sterility assurance. Although no illnesses or injuries have been reported, the potential for contamination and infection exists; this falls under the High category for risk-of-harm products without yet-reported injury.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, Model Number DYNJ50806L (Lot Number 23FBK937, UDI-DI: 10195327344672), due to calibration issues with the sterilization and packaging equipment used to process these devices.
The identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products. Although all products were exposed to validated sterilization and packaging cycles, the equipment calibration problems mean the devices may not meet required sterility standards.
The recalled kits were distributed nationwide in the United States. Consumers and healthcare facilities with these devices should contact Medline for guidance on how to proceed. The recall includes 32 units from the affected lot number.
The recalled product
- Product
- Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Convenience Kit
- Affected units
- 32
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 (4)
- 1) DYNJ50806L
- UDI-DI: 10195327344672(each)
- 40195327344673(case)
- Lot Number: 23FBK937
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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