Z-1713-2020Class III

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

Name: Z-1713-2020 Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper...
Creator: CooperSurgical, Inc.
Published: 2020-02-28
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2020-02-28 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product... on 2020-02-28. FDA classified it as Class III and gives the reason as "Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1713-2020
Classification: Class III
Status: Terminated
Initiated: 2020-02-28
Posted: 2020-04-15
Terminated: 2020-08-11
Recalling firm: CooperSurgical, Inc.
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.
Product code: MFD Cannula, Intrauterine Insemination
Reason for recall: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Distribution: International distribution to Japan only.
Product codes and lots: Lot number 250887

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1713-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1713-2020	Class III	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-15

Product code MFD

K964848Class IIWallace Artificial Insemination Catheter - 8Cm/18cmMarlow Surgical Technologies, Inc. / cleared 1997-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)