FDA Device recall Z-1241-2013
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the…
- FDA Device
- Class II
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class II recall of Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the… by Smiths Medical Asd, citing unable to pass catheter through outer sheath during embryo transfer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1241-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-05-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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.
Reason
Unable to pass catheter through outer sheath during embryo transfer
Identifiers
| code_info | Lot Codes: 2000102 2138834 2143444 2147484 2152583 2152584 2304183 2305244 2336960 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1241-2013%22
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