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.
FDA Recall Z-0714-2013 · Posted 2013-01-24
Recalling FirmMedisystems a NX Stage Company
Recall StatusTerminated
Product CodeFIE
Date Initiated2012-12-20
Date Terminated2013-10-10
Product Quantity26 casesx 250 needles (6500needles)
Reason for Recall
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution in the states of NY, PA and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.