FDA recall Z-1713-2020

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 for recall

Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.

Distribution

International distribution to Japan only.

Key facts

Status

Terminated

Initiation date

2020-02-28

Report date

2020-04-22

Termination date

2020-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2020