Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMA
Pending LLM rewrite. Source: FDA_DEVICE Z-1413-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. 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 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 — Devices
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.
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