Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters
Smiths Medical ASD, Inc. is recalling 800 Wallace Sure-Pro Single Stage Embryo Replacement Catheters because the catheter cannot be passed through the outer sheath during embryo transfer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that prevents the completion of a medical procedure (embryo transfer). This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the failure prevents the intended medical outcome but does not explicitly report physical injury or death.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 800 units of Wallace Sure-Pro Single Stage Embryo Replacement Catheters (Product Code: PP623). The recall is due to a defect where the catheter is unable to pass through the outer sheath during an embryo transfer procedure.
These catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. The affected products were distributed worldwide, including the United States and numerous international locations. The specific lot codes involved in this recall are 2000098, 2025748, 2041152, 2332539, and 2350024.
Clinicians and patients should stop using these specific catheters and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 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 adde
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot codes: 2000098 2025748 2041152 2332539 2350024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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