Device product
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Z-1194-2026
Product summary
- Event
- Event 98226
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-1194-2026
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 P903933B: UDI/DI 10889942362080 (EA) 40889942362081 (CS), Lot Number 25KMA871
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.