Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro Embryo Replace

FDA device recall Z-1243-2013 · posted 2013-05-03 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

Unable to pass catheter through outer sheath during embryo transfer

Action taken

The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated March 28, 2013 to its customers. The notification describes the product, problem and actions to be taken. The customers were provided with two options for proceeding: 1) continue to use product if the product passes a pre-test; or 2) return affected product to Smiths Medical for replacement or credit. In addition, the customers were instructed to inspect their inventory and quarantine all affected products; perform a count of affected products currently in inventory; complete and return the attached Confirmation Form via fax to +1-866-258-6068 or email to pamela.harrell@smiths-medical.com; send a copy of this notice to your customers identified having received affected product; and provide email confirmation of your customers notifications to Smiths medical at pamela.harrell@smiths-medical.com. Customers should report any issues with these products to Smiths Medicals Global Complaint Department at +1-866-216-8806 or globalcomplaints@smiths-medical.com. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at +1-800-258-5361.

Root cause

Process control

Status

Terminated

Product code

MQF

Quantity affected

4910 units

Distribution

Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain

Date initiated

2013-03-28

Date posted

2013-05-03

Date terminated

2021-05-19

Location

Keene, NH

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