Recall Z-1243-2013
Smiths Medical ASD, Inc. · initiated March 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 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.
Codes / lots: Lot Code: 2000103, 2025752, 2161556, 2165854, 2170929, 2304190, 2363603
Reason for recall
Unable to pass catheter through outer sheath during embryo transfer
FDA-determined cause: Process control
Action taken
The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated March 28, 2013 to its customers. The notification describes the product, problem and actions to be taken. The customers were provided with two options for proceeding: 1) continue to use product if the product passes a pre-test; or 2) return affected product to Smiths Medical for replacement or credit. In addition, the customers were instructed to inspect their inventory and quarantine all affected products; perform a count of affected products currently in inventory; complete and return the attached Confirmation Form via fax to +1-866-258-6068 or email to pamela.harrell@smiths-medical.com; send a copy of this notice to your customers identified having received affected product; and provide email confirmation of your customers notifications to Smiths medical at pamela.harrell@smiths-medical.com. Customers should report any issues with these products to Smiths Medicals Global Complaint Department at +1-866-216-8806 or globalcomplaints@smiths-medical.com. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at +1-800-258-5361.
Details
- Recall number
- Z-1243-2013
- Initiated
- March 28, 2013
- Posted by FDA
- May 3, 2013
- Terminated
- May 19, 2021
- Product code
- MQF – Catheter, Assisted Reproduction
- Quantity
- 4910 units
- Distribution
- Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO)…
- Recalling firm
- Smiths Medical ASD, Inc., Keene, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1239-2013 Class II | Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product…Unable to pass catheter through outer sheath during embryo transfer | 03/28/2013Terminated |
| Z-1240-2013 Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623…Unable to pass catheter through outer sheath during embryo transfer | 03/28/2013Terminated |
| Z-1241-2013 Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623…Unable to pass catheter through outer sheath during embryo transfer | 03/28/2013Terminated |
| Z-1242-2013 Class II | Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro…Unable to pass catheter through outer sheath during embryo transfer | 03/28/2013Terminated |
| Z-1244-2013 Class II | Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro…Unable to pass catheter through outer sheath during embryo transfer | 03/28/2013Terminated |