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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD, Inc.
- Reason for Recall:
- Unable to pass catheter through outer sheath during embryo transfer
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1242-2013
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