Recall Z-0724-2007 ยท NBW System, Test, Blood Glucose, Over The Counter
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Suture Passer 12 inch Part Number: 7209166
| Date | Apr 7, 2007 (initiated Mar 1, 2007) |
| Status | Terminated |
| Reason | Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use. |
| Root cause | Other |
| Action | Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed. |
| Quantity | 12, 292 units for all recalls Z-0724-0726-07 |
| Distribution | World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.