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U.S. Department of Health and Human Services

Class 2 Device Recall Guardia Access Nano Embryo Transfer Catheter, Catalog Number KJETS551910S

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  Class 2 Device Recall Guardia Access Nano Embryo Transfer Catheter, Catalog Number KJETS551910S see related information
Date Initiated by Firm October 03, 2019
Create Date November 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-0415-2020
Recall Event ID 84108
510(K)Number K983594  
Product Classification Catheter, assisted reproduction - Product Code MQF
Product Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Code Information Lot Number 9502915
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
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers. The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form. Returned Product should be addressed to: Cook Medical EUDC Robert-Koch-Stra¿e, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected products where applicable.
Quantity in Commerce 202
Distribution No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQF and Original Applicant = COOK OB/GYN
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