Z-1713-2020 Class III Terminated
FDA device recall Z-1713-2020 was initiated by CooperSurgical, Inc. on February 28, 2020 and is designated Class III. Reason for recall: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. The recall status is terminated (terminated August 11, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- February 28, 2020
- Termination Date
- August 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Reason for Recall
Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
Distribution Pattern
International distribution to Japan only.
Code Information
Lot number 250887