[pending] Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22
Pending LLM rewrite. Source: FDA_DEVICE Z-1195-2026.
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) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
- 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 (4)
- Medline Kit SKU DT22880: UDI/DI 10653160995470 (EA) 40653160995471 (CS)
- Lot Number 25KMJ441
- Medline Kit SKU DYNDC3283A: UDI/DI 10198459313240 (EA) 40198459313241 (CS)
- Lot Number 25KMH515.
Distribution
Distributed nationwide across the United States.
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