Z-0714-2013Class II

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set

Name: Z-0714-2013 Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set
Creator: Medisystems a NX Stage Company
Published: 2012-12-20
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2012-12-20 / Terminated / root cause: labeling and UDI

FDA source

Medisystems a NX Stage Company began a recall of 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... on 2012-12-20. FDA classified it as Class II and gives the reason as "A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0714-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-01-24
Terminated: 2013-10-10
Recalling firm: NxStage Medical Inc
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.
Product code: FIE Needle, Fistula
Reason for recall: A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot: 120719F4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0714-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0715-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23

Product code FIE

K990803Class IIMedisystems Buttonhole Needle SetsMedisystems Corp. / cleared 2000-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)