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Class 2 Device Recall Embryo Transfer Catheters/Sets |
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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
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Product Classification |
Catheter, assisted reproduction - Product Code MQF
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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
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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
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For Additional Information Contact |
Cook Medical Customer Relations Department 812-339-2235
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MQF and Original Applicant = COOK OB/GYN
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