Recall Z-0114-2009 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Sarstedt Inc
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
| Date | Oct 14, 2008 (initiated Aug 27, 2008) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.