Stryker PAINPUMP2

• 3 recalls, same reason

  • Terminated Z-2357-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010
  • Terminated Z-2359-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010
  • Terminated Z-2358-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010

  Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

1. 30 May 2003 Cleared FDA 510(k) K030661
2. 1 Feb 2010 Recall initiated FDA recalls Z-2357-2010
3. 1 Feb 2010 Recall initiated FDA recalls Z-2359-2010
4. 1 Feb 2010 Recall initiated FDA recalls Z-2358-2010

510(k) Number

K030661 ↗

FDA product code

MEA

Device class

Class II

Regulation

21 CFR Part 880.5725

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code MEA (Pump, Infusion, Pca).

• CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) by Smiths Medical Ads, Inc.
• VERIFUSE AMBULATORY PUMP by Block Medical, Inc.
• CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 by Sims Deltec, Inc.
• CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP by Pharmacia Deltec, Inc.
• PALM PUMP by Sorenson Medical, Inc.
• BARD PCA II PUMP WITH PROGRAM CARTRIDGES by C. R. Bard, Inc.
• ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 by Abbott Laboratories
• BAXA PCA INFUSOR by Baxa Corp., Sub. of Cook Group, Inc.
• GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES by Hennig Enterprises Europe Srl
• PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM by B. Braun Medical, Inc.

• Neptune

  Class IIa

  CE/MDR

• SmartLife

  Class I

  CE/MDR

• Nasopore

  Class I

  CE/MDR

• Otopore

  Class I

  CE/MDR

See all devices from Stryker Instruments →