Device product
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Z-1198-2026
Product summary
- Event
- Event 98226
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,928 total
- Official record key
device-enforcement:Z-1198-2026
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 DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25LMA655; Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25KMC911.
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.