Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
What this means for you
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 medical devices where a potential loss of sterility poses a high risk of harm, though no injuries have been reported.
Plain-English summary
Medline Industries, LP has identified issues regarding the calibration of equipment used to sterilize and package several Medline Convenience Kits. While all products were exposed to validated sterilization and packaging cycles, the calibration errors create a potential risk to the sterility assurance level (SAL) of the devices.
This recall affects various Medline Convenience Kits, including neuro shunts and various neuro packs, distributed worldwide and across the United States.
Consumers and healthcare providers should check their inventory for the affected model numbers and lot numbers listed in the official notice.
The recalled product
- Product
- Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 7,494
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) CDS860018G
- UDI-DI: 10889942459643(each)
- 40889942459644(case)
- Lot Number: 23CMH970
- 2) CDS860018G
- Lot Number: 23CMD444
- 3) CDS860018G
- Lot Number: 23AMJ086
- 4) CDS860018G
- Lot Number: 22KMF991
- 5) CDS860018G
- Lot Number: 22HMC764
- 6) CDS860018G
- Lot Number: 22DMD555
- 7) CDS860018G
- Lot Number: 21LMG598
- 8) CDS860018G
- Lot Number: 21KMD971
- 9) CDS860018G
- Lot Number: 21JMH357
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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