| Class 2 Device Recall Marrs Laparoscopic GIFT Catheters | |
Date Initiated by Firm | December 19, 2017 |
Create Date | March 26, 2018 |
Recall Status1 |
Terminated 3 on April 09, 2019 |
Recall Number | Z-1187-2018 |
Recall Event ID |
79471 |
510(K)Number | K983590 |
Product Classification |
Catheter, assisted reproduction - Product Code MQF
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Product | Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022
Product Usage:
Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use |
Code Information |
Lot Number: 5571684, Expiration Date: 1/12/2018 |
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 |
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 | 21 |
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
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