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.
Recall
- Recall Number
- Z-1713-2020
- Event Number
- 85139
- Firm
- CooperSurgical, Inc.
- FEI Number
- 1216677
- Product Code
- MFD
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- February 28, 2020
- Terminated
- August 11, 2020
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350
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.
Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
On 2/28/2020, Cooper Surgical issued a "Medical Device Field Safety Notice" for one lot number (250887) of the Wallace Intra-Uterine Insemination Catheters due to a discrepancy in the expiration dates on the individual pouches, inner and outer boxes. The notice was sent to the Japan authority (PMDA) and affected customers in both English and Japanese. The recall notice states that the affected lot (1170 units) of product manufactured in August 2018 have not resulted in any adverse events and the product is acceptable for use until the expiration date on August 23, 2021. Customers that prefer to return the product or have no product on hand were provided instructions to complete the Acknowledgement and Receipt form.
International distribution to Japan only.