Recall Z-1165-2007 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Lifescan Inc
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
| Date | Aug 16, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | Lancet tip may not fully retract and cause needle stick and exposure to used lancets. |
| Root cause | Nonconforming Material/Component |
| Action | The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users. The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed. |
| Quantity | 632 cartons (200 units per carton) |
| Distribution | Product was distributed nationwide to distributors and wholesale dealers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.