Smiths Medical Recalls Wallace Sure-Pro Ultra Embryo Catheters
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a functional failure of a medical device during a critical procedure, which poses a risk of harm or procedural failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters with Stylet (Product Code: PES623). These medical devices are used to introduce embryos into the uterine cavity following in vitro fertilization. The recall involves 11,550 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the catheter may be unable to pass through the outer sheath during the embryo transfer procedure. This defect could prevent the successful completion of the medical procedure. The affected lot codes are 2000102, 2138834, 2143444, 2147484, 2152583, 2152584, 2304183, 2305244, and 2336960.
Healthcare providers and patients should stop using these specific catheters immediately. Users should contact Smiths Medical ASD, Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 11,550
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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