Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN
Pending LLM rewrite. Source: FDA_DEVICE Z-1419-2026.
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) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
- 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) CDS982407N
- UDI-DI: 10193489683004(each)
- 40193489683005(case)
- Lot Number: 21DBO201
- 2) CDS982407N
- Lot Number: 21CBD150
- 3) CDS985431K
- UDI-DI: 10195327451295(each)
- 40195327451296(case)
- Lot Number: 23GBM332
- 4) CDS985431K
- Lot Number: 23GBL932
- 5) CDS985431O
- UDI-DI: 10198459195006(each)
- 40198459195007(case)
- Lot Number: 25GBB847
- 6) DYKMBNDL109A
- UDI-DI: 10193489848779(each)
- 40193489848770(case)
- Lot Number: 21IBS290
Distribution
Distributed nationwide across the United States.
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