Smiths Medical ASD, Inc.: Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 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-1240-2013

Recalling firm

Smiths Medical ASD, Inc.

Product

Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 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.

Status

Terminated

Initiated

2013-03-28

Posted

2013-05-03

Terminated

2021-05-19

Reason

Unable to pass catheter through outer sheath during embryo transfer

Root cause

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

59089 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).

Lot, serial or model codes

Lot Codes: 2000101 2044006 2044008 2044009 2065654 2117203 2117204 2120950 2138835 2152580 2152582 2156663 2165851 2165852 2170920 2170926 2295309 2304187 2304192 2304193 2304194 2304196 2304197 2304198 2305241 2305243 2313279 2324539 2327973 2327974 2336959 2341411 2341412 2341414 2341415 2341416 2341420

510(k) numbers

["K033084","K990349","K990350"]

PMA numbers

not on file

Product code

MQF

Firm FEI

1217052

Firm city

Keene

Firm state

NH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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