Device 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.
Z-1195-2026
Product summary
- Event
- Event 98226
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,928 total
- Official record key
device-enforcement:Z-1195-2026
Official wording
Reason: 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.
Code information: 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 pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.