Device product
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545
Z-1800-2022
Product summary
- Event
- Event 90731
- Status
- Ongoing
- Classification
- Class III
- Quantity
- a. 6 bx b. 308 cs.
- Official record key
device-enforcement:Z-1800-2022
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Code information: GTIN: a. 10381780491781 EA; 30381780491785 CS. b. 10381780491675 EA; 30381780491679 CS
Distribution pattern: US Nationwide distribution.
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.