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U.S. Department of Health and Human Services

Class 2 Device Recall Buttonhole Needle Set

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 Class 2 Recall
Buttonhole Needle Set
see related information
Date Posted January 24, 2013
Recall Status1 Terminated on October 10, 2013
Recall Number Z-0714-2013
Recall Event ID 63959
Premarket Notification
510(K) Number
K990803 
Product Classification Needle, Fistula - Product Code FIE
Product Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Code Information Lot: 120719F4
Recalling Firm/
Manufacturer
Medisystems a NX Stage Company
350 Merrimack St
Lawrence, Massachusetts 01843-1748
Manufacturer Reason
for Recall
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.
Quantity in Commerce 26 casesx 250 needles (6500needles)
Distribution US Nationwide Distribution in the states of NY, PA and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FIE and Original Applicant = MEDISYSTEMS CORP.
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