Home / Recalls / Aspen Surgical Products, Inc. / Z-2390-2021

Z-2390-2021 Class II Terminated

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

FDA device recall Z-2390-2021 was initiated by Aspen Surgical Products, Inc. on July 23, 2021 and is designated Class II. Reason for recall: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide … The recall status is terminated (terminated July 26, 2022). Affected quantity: 124.

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
July 23, 2021
Termination Date
July 26, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124

Product Description

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Reason for Recall

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

Distribution Pattern

US nationwide distribution. No foreign distribution.

Code Information

All lots manufactured between July 9, 2019 to July 9, 2021

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-2388-2021 Class II — Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 1 (July 23, 2021)
  • Z-1424-2014 Class II — 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) (March 20, 2014)
  • Z-1422-2014 Class II — Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended (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-1418-2014 Class II — 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10 (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)
  • Z-1419-2014 Class II — 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System (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-1423-2014 Class II — 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Inten (March 20, 2014)

FDA data resources