Date Initiated by Firm | December 20, 2012 |
Date Posted | January 24, 2013 |
Recall Status1 |
Terminated 3 on October 10, 2013 |
Recall Number | Z-0714-2013 |
Recall Event ID |
63959 |
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 MA 01843-1748
|
For Additional Information Contact | 978-687-4700 |
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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = FIE
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