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U.S. Department of Health and Human Services

Class 2 Device Recall Wallace SurePro Single Stage Embryo Replacement Catheter

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 Class 2 Recall
Wallace SurePro Single Stage Embryo Replacement Catheter
see related information
Date Posted May 03, 2013
Recall Status1 Open
Recall Number Z-1244-2013
Recall Event ID 64705
Premarket Notification
510(K) Numbers
K033084  K990349  K990350 
Product Classification Catheter, Assisted Reproduction - Product Code MQF
Product Wallace Sure-Pro® Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro® Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra® Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Code Information Lot codes: 2000098 2025748 2041152 2332539 2350024
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene, New Hampshire 03431-5043
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Unable to pass catheter through outer sheath during embryo transfer
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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.
Quantity in Commerce 800 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 (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQF and Original Applicant = COOPERSURGICAL, INC.
510(K)s with Product Code = MQF and Original Applicant = PORTEX LTD.
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