The Recall Desk
LowFDA (Devices)·Z-1713-2020·Announced 2020-04-22

CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date.

Plain-English summary

CooperSurgical, Inc. is recalling Wallace Artificial Insemination Catheters, 180 mm, Sterile, Model AIC18JP. The recall is due to an expiration date discrepancy where the product was marked with a 5-year expiration date, but the correct expiration date is 3 years.

The affected product is Lot number 250887. The distribution was limited to Japan only. The intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm for instructions on return or replacement.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number 250887

Distribution

Distribution scope not specified by the agency.