FDA Medical Device Recalls (openFDA)
Medisystems a NX Stage Company: 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 in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
- Recall number
- Z-0715-2013
- Recalling firm
- Medisystems a NX Stage Company
- 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 in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
- Status
- Terminated
- Initiated
- 2012-12-20
- Posted
- 2013-01-24
- Terminated
- 2013-10-10
- Reason
- Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
- 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
- 16 cases (15 cs x 250 ea) 4,000 needles
- Distribution
- US Nationwide Distribution in the states of NY, PA and TN.
- Lot, serial or model codes
- Lot: Number: 110914F8
- 510(k) numbers
- K910734
- PMA numbers
- not on file
- Product code
- FIE
- Firm FEI
- 3003464075
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28