Medical device recalls

CooperSurgical, Inc. recalls Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical…

Recall date
February 28, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1713-2020
FDA classification
Class III
Brand / firm
CooperSurgical, Inc.
Sold / distributed
International distribution to Japan only.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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