FDA Medical Device Recalls (openFDA)
Nipro Medical Corporation: NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
- Recall number
- Z-0599-2016
- Recalling firm
- Nipro Medical Corporation
- Product
- NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
- Status
- Terminated
- Initiated
- 2014-04-01
- Posted
- not on file
- Terminated
- 2016-12-14
- Reason
- Device has the potential to have torn wings.
- Root cause
- Process control
- Action
- The only one Distributor was notified (2014) by e-mail by the firm of the quality deficiency before the product arrived at their facility. It was immediately returned to Nipro Medical when it arrived.
- Quantity
- 160,000 pieces.
- Distribution
- US distribution including TN.
- Lot, serial or model codes
- Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.
- 510(k) numbers
- ["K032777"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1000132332
- Firm city
- Miami
- Firm state
- FL
- 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