FDA Medical Device Recalls (openFDA)
Sarstedt Inc: Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
- Recall number
- Z-0114-2009
- Recalling firm
- Sarstedt Inc
- Product
- Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
- Status
- Terminated
- Initiated
- 2008-08-27
- Posted
- 2008-10-14
- Terminated
- 2012-04-24
- Reason
- 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
- 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
- 1000 pieces
- Distribution
- NC
- Lot, serial or model codes
- Product #85.1015.050, Lot #M40C219A7
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 2242368
- Firm city
- Newton
- Firm state
- NC
- 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