One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
- Company
- Lifescan Inc
- Recall Initiated
- March 30, 2007
- Posted
- August 16, 2007
- Terminated
- December 3, 2007
- Recall Number
- Z-1165-2007
- Quantity
- 632 cartons (200 units per carton)
- Firm Location
- Milpitas, CA
Reason for Recall
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Distribution
Product was distributed nationwide to distributors and wholesale dealers.
Lot / Code Info
Lot SA4426; Part number 021-140-01
Root Cause
Nonconforming Material/Component
Action Taken
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.
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