[pending] Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1199-2026.
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) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
- 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 (6)
- Medline Kit SKU DYNJ35494C: UDI/DI 10198459117879 (EA) 40198459117870 (CS)
- Lot Number 25KMD420
- Medline Kit SKU DYNJ38582O: UDI/DI 10198459603709 (EA) 40198459603700 (CS)
- Lot Number 25KMI679
- Medline Kit SKU DYNJ82084F: UDI/DI 10198459089206 (EA) 40198459089207 (CS)
- Lot Number 25KMD145.
Distribution
Distributed nationwide across the United States.
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