Z-0271-06

LifeScan OneTouch SureSoft Lancing Device, single use lancing device

Name: Z-0271-06 LifeScan OneTouch SureSoft Lancing Device, single use lancing device
Creator: Lifescan Inc
Published: 2005-10-11
License: https://open.fda.gov/license/

Lifescan, Inc. / initiated 2005-10-11 / Terminated

FDA source

Lifescan Inc began a recall of LifeScan OneTouch SureSoft Lancing Device, single use lancing device on 2005-10-11. The reason FDA records is "In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0271-06
Status: Terminated
Initiated: 2005-10-11
Posted: 2005-12-08
Terminated: 2006-11-21
Recalling firm: Lifescan, Inc.
Product: LifeScan OneTouch SureSoft Lancing Device, single use lancing device.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
FDA root cause: Other
Action: On October 11, 2005, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Quantity in commerce: 1123 boxes
Distribution: Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.
Product codes and lots: Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395. Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.

Product code NBW

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)