Device product
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
Z-1584-2022
Product summary
- Event
- Event 90336
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 cases
- Official record key
device-enforcement:Z-1584-2022
Official wording
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Code information: GTIN: 15712123000288; 25712123000285 Lot 262801 Lots Distributed: 6/1/2021 - 6/2/2021
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.