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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Wallace Sure-Pro Ultra® Embryo Replacement Catheter with Stylet Product Code:PES623 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.
Recall Number Z-1241-2013
Classification Class II
Code Info Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960
Product Distributed Qty 11550 units
Reason For Recall Unable to pass catheter through outer sheath during embryo transfer

Event Detail

Event Id 64705
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Keene
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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).
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