[pending] Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1086-2026.
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 kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF,
- 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)
- REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS)
- Kit Lot Number 25EMH913
- Kit Lot Number 25EMC376
- Kit Lot Number 25CMJ688
- Kit Lot Number 25CME476
- REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS)
- Kit Lot Number 25EBM987
- Kit Lot Number 25CBT666
- REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS)
- Kit Lot Number 25FBP815
- Kit Lot Number 25EBN002
- Kit Lot Number 25CBN212
- REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS)
- Kit Lot Number 25FBN760
- Kit Lot Number 25EBD329
- Kit Lot Number 25DBN040
- Kit Lot Number 25DBK313
- Kit Lot Number 25CBE452
- REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS)
- Kit Lot Number 25DMH793
Distribution
Distributed nationwide across the United States.
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