Recall Z-1713-2020 ยท MFD Cannula, Intrauterine Insemination
CooperSurgical, Inc.
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.
| Date | Feb 28, 2020 |
| Status | Terminated |
| Reason | Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. |
| Root cause | Labeling Change Control |
| Action | 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 t |
| Distribution | International distribution to Japan only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964848 | WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM Marlow Surgical Technologies, Inc., Jan 16, 1997 |