Z-1241-2013Class II

Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet

Name: Z-1241-2013 Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet
Creator: Smiths Medical ASD, Inc.
Published: 2013-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-03-28 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro Embryo Replacement Catheters are used for the introduction of... on 2013-03-28. FDA classified it as Class II and gives the reason as "Unable to pass catheter through outer sheath during embryo transfer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1241-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-05-03
Terminated: 2021-05-19
Recalling firm: Abbott Medical
Product: 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.
Product code: MQF Catheter, Assisted Reproduction
Reason for recall: Unable to pass catheter through outer sheath during embryo transfer
Root cause tag: manufacturing process
FDA 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 [email protected]; 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 [email protected]. Customers should report any issues with these products to Smiths Medicals Global Complaint Department at +1-866-216-8806 or [email protected]. 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: 11550 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).
Product codes and lots: Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1240-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1241-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1242-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1243-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03
Z-1244-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03

Product code MQF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)