Recall Z-0271-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
| Date | Dec 8, 2005 (initiated Oct 11, 2005) |
| Status | Terminated |
| Reason | In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks. |
| Root cause | Other |
| Action | On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 1123 boxes |
| Distribution | Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.