Device product
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Z-0295-2020
Product summary
- Event
- Event 83633
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total number in recall for all products in dist: 49,130 units
- Official record key
device-enforcement:Z-0295-2020
Official wording
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Code information: Lot numbers 11228251 and 11229805
Distribution pattern: Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Derived failure modes
-
Sterility assurance
loss of sterility