Device product
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
Z-1713-2020
Product summary
- Event
- Event 85139
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1713-2020
Official wording
Reason: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
Code information: Lot number 250887
Distribution pattern: International distribution to Japan only.
Derived failure modes
-
Unknown
Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.