FDA Device recall Z-1242-2013
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the intro…
- FDA Device
- Class II
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class II recall of Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the intro… 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-1242-2013 |
| 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¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 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: 2000100 2025750 2044018 2044019 2065655 2120952 2152589 2152590 2156664 2156665 2170927 2295308…Lot codes: 2000100 2025750 2044018 2044019 2065655 2120952 2152589 2152590 2156664 2156665 2170927 2295308 2305235 2305236 2305237 2305238 2308139 2308141 2313280 2313281 2320238 2324603 2336961 2341418 2359095 2363587 2363588 2363589 2363592 2363593 2363594 2363595 2363596 2363597 2363598 |
|---|
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-1242-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.