[pending] Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-1421-2026.
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: Pending LLM scoring against the rubric.
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) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
- 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) CDS940087AG
- UDI-DI: 10193489847260(each)
- 40193489847261(case)
- Lot Number: 21EBC900
- 2) CDS940087AI
- UDI-DI: 10193489933758(each)
- 40193489933759(case)
- Lot Number: 22GBE442
- 3) CDS940087AI
- Lot Number: 22EBG548
- 4) CDS940087AI
- Lot Number: 22EBF695
- 5) CDS940087AI
- Lot Number: 22EBA274
- 6) CDS940087AI
- Lot Number: 22BBY060
- 7) CDS940087AI
- Lot Number: 21KBH163
- 8) CDS940087AI
- Lot Number: 21JBF936
Distribution
Distributed nationwide across the United States.
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