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U.S. Department of Health and Human Services

Class 2 Device Recall Embryo Transfer Catheters/Sets

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  Class 2 Device Recall Embryo Transfer Catheters/Sets see related information
Date Initiated by Firm December 19, 2017
Create Date March 26, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-1188-2018
Recall Event ID 79471
510(K)Number K983594  
Product Classification Catheter, assisted reproduction - Product Code MQF
Product 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740
Code Information 1. Catalog Number: K-J-SMS-571800, Lot Number: 6802704, Expiration Date: 3/10/2019; 2. Catalog Number: K-JETS-551910-L, Lot Number: NS6360603, Expiration Date: 11/15/2018; 3. Catalog Number: K-JETS-7019-SIVF, Lot Number: 6503675, Expiration Date: 2/2/2019   
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		 Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
FDA Determined
Cause 2		 Process control
Action Cook Medical sent an Urgent Medical Device Recall dated December 19, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Examine inventory immediately and quarantine affected product(s). 2. Return products to Cook with the Acknowledgement and Receipt Form to receive a product credit. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4.Report adverse events to Cook. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Quantity in Commerce 473
Distribution Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
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 = MQF and Original Applicant = COOK OB/GYN
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