Percutaneous Nephrostomy Set

• 3 recalls, same reason

  • Terminated Z-1346-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009 ·on shared 510(k) K820867
  • Terminated Z-1339-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009
  • Terminated Z-1345-2009 FDA Unclassified (pre-2012) ·initiated 18 Mar 2009 ·on shared 510(k) K820867

  Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

• • Terminated Z-1106-04 FDA Unclassified (pre-2012) ·initiated 25 Jun 2004

  Mislabeled as to size; 10FR are labeled as 8FR.

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

510(k) Number

K820867 ↗

FDA Product Code

GBO

Device Class

Class I

Regulation

21 CFR Part 878.4200

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Segura Stone Basket W/Protective Sheath

  Class II

  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Bladder Evacuator

  Class II

  FDA 510(k) K880099 Active Cleared 2 Mar 1988

See all devices from Van-Tec, Inc. →