Medisystems 17 Gauge AV Fistula Needles Recalled for Mislabeling
Medisystems is recalling 17 Gauge AV Fistula Needles because single needle packs are mislabeled as 15 Gauge. The recall covers 4,000 needles distributed in New York, Pennsylvania, and Tennessee.
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 and involves a minor labeling error where the gauge is misidentified, which fits the rubric criteria for moderate severity.
Plain-English summary
Medisystems, a NX Stage Company, is recalling 17 Gauge x 1 inch AV Fistula Needles (Product Code: D9-2007MGLB) due to a labeling error. The single needle packs within the cases are mislabeled on the pouch as 15 Gauge needles instead of the correct 17 Gauge.
The recall involves 16 cases, containing a total of 4,000 needles. These products were distributed nationwide in the states of New York, Pennsylvania, and Tennessee. The specific lot number for the recalled items is 110914F8.
These needles are indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. Users should verify the gauge of their needles against the packaging and contact the manufacturer or their supplier for further instructions regarding the mislabeled products.
The recalled product
- Product
- Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use…
- Manufacturer
- Medisystems a NX Stage Company
- Category
- Medical Device — Needles
- Hazard
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: Number: 110914F8
Distribution
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 →Related recalls
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