Recall Z-1240-2013— Smiths Medical ASD, Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2013-03-28, terminated 2021-05-19. It names 3 FDA 510(k) clearances: K033084, K990349, K990350. 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.. Reason: Unable to pass catheter through outer sheath during embryo transfer.
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2021-05-19
- Firm location
- Keene, NH, United States
510(k) clearances named in this recall
3 on FDA's record- K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
- K990349 — WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
- K990350 — WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Unable to pass catheter through outer sheath during embryo transfer
Data sourced from openFDA. This site is unofficial and independent of the FDA.