[pending] Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYN
Pending LLM rewrite. Source: FDA_DEVICE Z-1197-2026.
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 were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU D
- 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 (16)
- Medline Kit SKU DYNJ0395022O: UDI/DI 10195327634827 (EA) 40195327634828 (CS)
- Lot Number 25KME682
- Medline Kit SKU DYNJ0415776Q: UDI/DI 10198459566806 (EA) 40198459566807 (CS)
- Lot Number 25KMH125
- Medline Kit SKU DYNJ04811O: UDI/DI 10198459440953 (EA) 40198459440954 (CS)
- Lot Number 25KMD772
- Medline Kit SKU DYNJ44864S: UDI/DI 10195327127626 (EA) 40195327127627 (CS)
- Lot Number 25LMA115
- Medline Kit SKU DYNJ50880L: UDI/DI 10198459388002 (EA) 40198459388003 (CS)
- Lot Number 25LMA516
- Medline Kit SKU DYNJ82244B: UDI/DI 10198459344053 (EA) 40198459344054 (CS)
- Lot Number 25KMF328
- Medline Kit SKU DYNJ82761B: UDI/DI 10198459039232 (EA) 40198459039233 (CS)
- Lot Number 25LMA391
- Medline Kit SKU DYNJT4964: UDI/DI 10198459460098 (EA) 40198459460099 (CS)
- Lot Number 25KMJ341.
Distribution
Distributed nationwide across the United States.
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