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

• Date Initiated by Firm: October 03, 2019
• Create Date: November 16, 2019
• Recall Status: Terminated on May 13, 2020
• 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: 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-Strae, 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 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