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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Lancet

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  Class 2 Device Recall Safety Lancet see related information
Date Initiated by Firm August 27, 2008
Date Posted October 14, 2008
Recall Status1 Terminated 3 on April 24, 2012
Recall Number Z-0114-2009
Recall Event ID 49416
Product Classification Lancet - Product Code FMK
Product Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet)
Code Information Product #85.1015.050, Lot #M40C219A7
Recalling Firm/
Manufacturer
Sarstedt Inc
1025 Saint James Church Rd
Newton NC 28658-8627
For Additional Information Contact Mr. Peter Rumswinkel
828-465-4000
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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