[pending] Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1190-2026.
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) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, K
- 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)
- Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS)
- Lot Number 25KMD733
- Lot Number 25KMC147
- Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS)
- Lot Number 25KMJ151
- Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS)
- Lot Number 25LMB220
- Lot Number 25KME804
- Medline Kit SKU DYNJ51440B: UDI/DI 10198459004230 (EA) 40198459004231 (CS)
- Lot Number 25KMI445
- Medline Kit SKU DYNJ58742J: UDI/DI 10198459254710 (EA) 40198459254711 (CS)
- Lot Number 25KMC534
- Medline Kit SKU DYNJ63781B: UDI/DI 10198459549595 (EA) 40198459549596 (CS)
- Lot Number 25KMB410
- Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS)
- Lot Number 25LMB068
- Lot Number 25KMI309
- Medline Kit SKU DYNJ82753C: UDI/DI 10198459446887 (EA) 40198459446888 (CS)
- Lot Number 25KMC126
- Medline Kit SKU DYNJ907206G: UDI/DI 10198459368028 (EA) 40198459368029 (CS)
Distribution
Distributed nationwide across the United States.
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