Device product
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Z-1353-2015
Product summary
- Event
- Event 70609
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274
- Official record key
device-enforcement:Z-1353-2015
Official wording
Reason: Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
Code information: Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016
Distribution pattern: Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
Derived failure modes
-
Unknown
Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.