One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
FDA device recall Z-1165-2007 · posted 2007-08-16 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMK
- Quantity affected
- 632 cartons (200 units per carton)
- Distribution
- Product was distributed nationwide to distributors and wholesale dealers.
- Date initiated
- 2007-03-30
- Date posted
- 2007-08-16
- Date terminated
- 2007-12-03
- Location
- Milpitas, CA
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