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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm February 28, 2020
Create Date April 15, 2020
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-1713-2020
Recall Event ID 85139
510(K)Number K964848  
Product Classification Cannula, Intrauterine Insemination - Product Code MFD
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.
Code Information Lot number 250887
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MFD and Original Applicant = MARLOW SURGICAL TECHNOLOGIES, INC.
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