Home / Recalls / Aspen Surgical Products, Inc. / Z-1435-2014

Z-1435-2014 Class II Terminated

Recalled by Aspen Surgical Products, Inc. — Caledonia, MI

Recall Details

Product Type
Devices
Report Date
April 16, 2014
Initiation Date
March 20, 2014
Termination Date
November 25, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)

Reason for Recall

The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

Distribution Pattern

Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.

Code Information

Product Number 340004, 332259, 310003

Other recalls by Aspen Surgical Products, Inc.

  • Z-2389-2021 Class II — Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 10 (July 23, 2021)
  • Z-2390-2021 Class II — Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit (July 23, 2021)
  • Z-2388-2021 Class II — Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 1 (July 23, 2021)
  • Z-1417-2014 Class II — 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/ (March 20, 2014)
  • Z-1423-2014 Class II — 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Inten (March 20, 2014)
  • Z-1422-2014 Class II — Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended (March 20, 2014)
  • Z-1424-2014 Class II — 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) (March 20, 2014)
  • Z-1421-2014 Class II — Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) (March 20, 2014)
  • Z-1425-2014 Class II — 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) (March 20, 2014)
  • Z-1429-2014 Class II — 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/ (March 20, 2014)