Home / Recalls / Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical / Z-1721-2019

Z-1721-2019 Class II Terminated

Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical — Orange, CA

Recall Details

Product Type
Devices
Report Date
June 12, 2019
Initiation Date
July 13, 2018
Termination Date
May 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31904

Product Description

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Reason for Recall

Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Distribution Pattern

AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.

Code Information

Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17 1038A, 17 1083, 17 1193, 17 1262, 17 2122, 17 2142, 17 2219, 17 2306, 17 2347A, 18 1092B, 18 1121, 18 2037, and 18 3164.

Other recalls by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

  • Z-1824-2020 Class II — Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial (February 25, 2020)
  • Z-2259-2013 Class II — NX3 Try-In Gel. The product is used as a tooth shade resin material. (September 13, 2013)
  • Z-1076-2013 Class II — Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 3441 (February 22, 2013)