FDA Medical Device Recalls (openFDA)
Lifescan Inc: One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
- Recall number
- Z-1165-2007
- Recalling firm
- Lifescan Inc
- Product
- One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
- Status
- Terminated
- Initiated
- 2007-03-30
- Posted
- 2007-08-16
- Terminated
- 2007-12-03
- 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.
- Lot, serial or model codes
- Lot SA4426; Part number 021-140-01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28