FDA Medical Device Recalls (openFDA)
Nipro Medical Corporation: Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
- Recall number
- Z-0161-2016
- Recalling firm
- Nipro Medical Corporation
- Product
- Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
- Status
- Terminated
- Initiated
- 2015-08-13
- Posted
- 2015-10-23
- Terminated
- 2017-10-13
- Reason
- Some 1 1/4" needles were packaged and labeled in the 1" blister package.
- Root cause
- Mixed-up of materials/components
- Action
- Customers were issued a RMA 60001203 on August 18, 2015.
- Quantity
- 50,000 pieces
- Distribution
- Indiana
- Lot, serial or model codes
- Lot # 15C03
- 510(k) numbers
- ["K071145"]
- PMA numbers
- not on file
- Product code
- LLB
- 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