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Terminated

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.

FDA Recall Z-1713-2020 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeMFD
Date Initiated2020-02-28
Date Terminated2020-08-11

Reason for Recall

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

Firm 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 to return the product or have no product on hand were provided instructions to complete the Acknowledgement and Receipt form.

Root Cause

Labeling Change Control

Distribution Pattern

International distribution to Japan only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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