Z-1165-2007

One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200

Name: Z-1165-2007 One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
Creator: Lifescan Inc
Published: 2007-03-30
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2007-03-30 / Terminated / root cause: manufacturing process

FDA source

Lifescan Inc began a recall of One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 on 2007-03-30. The reason FDA records is "Lancet tip may not fully retract and cause needle stick and exposure to used lancets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1165-2007
Status: Terminated
Initiated: 2007-03-30
Posted: 2007-08-16
Terminated: 2007-12-03
Recalling firm: Lifescan, Inc.
Product: One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
Root cause tag: manufacturing process
FDA 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 in commerce: 632 cartons (200 units per carton)
Distribution: Product was distributed nationwide to distributors and wholesale dealers.
Product codes and lots: Lot SA4426; Part number 021-140-01

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)