FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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.
- Recall number
- Z-2192-2013
- Recalling firm
- Becton Dickinson & Company
- 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.
- Status
- Terminated
- Initiated
- 2013-07-10
- Posted
- 2013-09-11
- Terminated
- 2014-03-19
- Reason
- The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
- 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
- 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.
- Lot, serial or model codes
- REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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