[pending] Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237
Pending LLM rewrite. Source: FDA_DEVICE Z-1087-2026.
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) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHO
- 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 CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS)
- Lot Number 25FBK870
- Lot Number 25EBD110
- REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS)
- Lot Number 25EBC253
- Lot Number 25DBG393
- REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
- Lot Number 25FBQ303
- Lot Number 25EBD631
- Lot Number 25DBM322
- REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS)
- Lot Number 25DBT807
- REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS)
- Lot Number 25DMG099
- Lot Number 25CMJ006
- REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS)
- Lot Number 25FDB347
- REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS)
- Lot Number 25EBK539
- Lot Number 25DBD145
Distribution
Distributed nationwide across the United States.
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