[pending] Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS9
Pending LLM rewrite. Source: FDA_DEVICE Z-1189-2026.
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) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
- 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 CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS)
- Lot Number 25KMI898
- Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS)
- Lot Number 25KMH748
- Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS)
- Lot Number 25KME009.
Distribution
Distributed nationwide across the United States.
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