Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter recall
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the…
Why was Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter recalled?
Unable to pass catheter through outer sheath during embryo transfer
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: 2000101 2044006 2044008 2044009 2065654 2117203 2117204 2120950 2138835 2152580 2152582 2156663 2165851 2165852 2170920 2170926 2295309 2304187 2304192 2304193 2304194 2304196 2304197 2304198 2305241 2305243 2313279 2324539 2327973 2327974 2336959 2341411 2341412 2341414 2341415 2341416 2341420
- Product
- Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the…
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 59089 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), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
- Recall date
- May 15, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)