Z-0114-2009

Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)

Name: Z-0114-2009 Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
Creator: Sarstedt Inc
Published: 2008-08-27
License: https://open.fda.gov/license/

Sarstedt ApS / initiated 2008-08-27 / Terminated / root cause: manufacturing process

FDA source

Sarstedt Inc began a recall of Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) on 2008-08-27. The reason FDA records is "The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated". 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-0114-2009
Status: Terminated
Initiated: 2008-08-27
Posted: 2008-10-14
Terminated: 2012-04-24
Recalling firm: Sarstedt ApS
Product: Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: The product from this lot may not retract the lancet into the safe position inside the lancet body after the trigger is actuated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The consignee was notified via letter that was hand delivered on 08/27/2008. All of the distributed product was picked up from the consignee and returned to Sarstedt, Inc. None of the product had been used. All action was completed on 8/27/2008. Contact Sarstedt at 1-828-465-4000 for assistance.
Quantity in commerce: 1000 pieces
Distribution: NC
Product codes and lots: Product #85.1015.050, Lot #M40C219A7

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)