Gripper Plus Needle

• • Terminated Z-0253-2020 FDA Class II ·initiated 15 Jul 2019 ·on shared 510(k) K021999

  Supplier initiated recall of the GRIPPER Needles

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021999 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cadd High-Volume Administration Sets with Flowstop Open recall

  Class II

  FDA 510(k) K031361 Active Cleared 23 May 2003

• Truflow Dual-Lumen Polyurethane Long-Term Straight Dialysis Catheter (12.5 Fr X 24 Cm) with Tray, Truflow Dual-Lumen Poy

  Class II

  FDA 510(k) K030983 Active Cleared 25 Apr 2003

• Deltec Insulin Infusion Pump and Accessories

  Class II

  FDA 510(k) K020655 Active Cleared 13 Aug 2002

• Truflow Long-Term and Short-Term Dual-Lumen Dialysis Catheters

  Class II

  FDA 510(k) K022221 Active Cleared 30 Jan 2003