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Class 2 Device Recall Wallace SurePro/ SurePro Ultra Embryo Replacement Catheters |
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Date Initiated by Firm |
March 28, 2013 |
Date Posted |
May 03, 2013 |
Recall Status1 |
Terminated 3 on May 19, 2021 |
Recall Number |
Z-1239-2013 |
Recall Event ID |
64705 |
510(K)Number |
K033084 K990350 K990349
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Product Classification |
Catheter, assisted reproduction - Product Code MQF
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Product |
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623
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: 2000099 2044001 2044005 2117201 2117202 2120953 2138832 2138833 2161554 2304181 2304182 2304199 2305239 2305240 2308138 2313278 2332537 2336956 2336957 2341409 2341410 2344790 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 10 Bowman Dr Keene NH 03431-5043
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For Additional Information Contact |
603-352-3812 Ext. 2782
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Manufacturer Reason for Recall |
Unable to pass catheter through outer sheath during embryo transfer
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FDA Determined Cause 2 |
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 |
22380 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
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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 and Original Applicant = COOPERSURGICAL, INC. 510(K)s with Product Code = MQF and Original Applicant = PORTEX LTD.
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