CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

Regimen 28 Day - Glutaraldehyde Sterilizing recalled by Kerr/Pentron

Kerr/Pentron is recalling Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution, distributed in 21 states. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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.

Quantity recalled31904

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1721-2019
FDA event ID: 82553
Recalling firm: Kerr/Pentron, Orange, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2018
FDA classified: 4 Jun 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jul 2018	Recall initiated by company
4 Jun 2019	Classified by FDA	+326 days
12 Jun 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Where it was distributed

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

Arizona California Colorado Florida Georgia Illinois Kentucky Louisiana Massachusetts Minnesota Missouri New Jersey New York Ohio Pennsylvania South Carolina Tennessee Texas Utah Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Kerr/Pentron

All 4

Reported	Class	Recall	Company	Reason	Where
6 May 2020Device	CLASS II	Nexus Universal with OptiBond Universal recalled by Kerr/Pentron	Kerr/Pentron	Packaging Defects	Nationwide
25 Sep 2013Device	CLASS II	NX3 Try-In Gel recalled by Kerr/Pentron	Kerr/Pentron	Device Malfunction	Nationwide
17 Apr 2013Device	CLASS II	Kerr Maxcem Elite, self-etch/self-adhesive resin cement recalled	Kerr/Pentron	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide