Recall Z-1713-2020— CooperSurgical, Inc.
Class III · Terminated
Class III FDA medical device recall by CooperSurgical, Inc., initiated 2020-02-28, terminated 2020-08-11. It names one FDA 510(k) clearance: K964848. 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.. Reason: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-02-28
- Terminated
- 2020-08-11
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.