FDAClass IIJanuary 30, 2013

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set recall: Labeling Error

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use…

Why was Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set recalled?

A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 120719F4

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…
Recalling firm
Medisystems a NX Stage Company
Quantity
26 casesx 250 needles (6500needles)
Distribution
US Nationwide Distribution in the states of NY, PA and TN.
Recall date
January 30, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls