Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0714-2013·Announced 2013-01-30

Medisystems Buttonhole Needle Set Recalled for Mislabeled Length

Medisystems is recalling 5 mislabeled buttonhole needle pouches that were labeled as 15 Ga x 1 inch instead of 15 Ga x 3/5 inch.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a minor labeling error (length mislabeling) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medisystems, a NX Stage Company, is recalling 5 single needle pouches of the 15 Gauge x 3/5 inch Buttonhole Needle Set (Product Code: BH-2035PE). The recall is due to a labeling error where the pouches were mislabeled as 15 Ga x 1 inch instead of the correct 15 Ga x 3/5 inch.

The affected product is indicated for use as an access device for dialysis and pheresis procedures using a constant site or buttonhole method of needle insertion. The recall involves a total of 5 single needle pouches from Lot 120719F4. The product was distributed in the United States, specifically in the states of New York, Pennsylvania, and Tennessee.

Healthcare providers and patients should stop using the affected needle pouches and contact Medisystems for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer: Medisystems a NX Stage Company
Category: Medical Device — Needles
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot: 120719F4

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medisystems a NX Stage Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medisystems a NX Stage Company

See all →

Moderate
Medisystems 17 Gauge AV Fistula Needles Recalled for Mislabeling
FDA (Devices) · 2013-01-30

Same hazard · mis labeling