Medisystems 17 Gauge x 1" inch AV Fistula Needle recall: Labeling Error
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector…
Why was Medisystems 17 Gauge x 1" inch AV Fistula Needle recalled?
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
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: Number: 110914F8
- Product
- Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector…
- Recalling firm
- Medisystems a NX Stage Company
- Quantity
- 16 cases (15 cs x 250 ea) 4,000 needles
- 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)