Device product
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
Z-1187-2026
Product summary
- Event
- Event 98226
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,928 total
- Official record key
device-enforcement:Z-1187-2026
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 DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.
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.