Z-2192-2013Class II

BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton...

Name: Z-2192-2013 BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton...
Creator: Becton Dickinson & Company
Published: 2013-07-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-07-10 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made... on 2013-07-10. FDA classified it as Class II and gives the reason as "The Lancet will not retract after activation thus creating a potential for exposure to a used sharp". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2192-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-10
Posted: 2013-09-11
Terminated: 2014-03-19
Recalling firm: Becton Dickinson & Co
Product: BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
FDA root cause: Component change control
Action: BD notified their customers and distributors by phone, e-mail, and/or letter/notice of return/ customer packing list on 7/10/2013.
Quantity in commerce: US - 39,800 units ; Canada - 18,400 units
Distribution: Distributed in the states of CT, KY, IL, NY, PA, TX, and VA and the country of Canada.
Product codes and lots: REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2192-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2192-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

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)