FDAClass IIJune 12, 2019

Regimen 28 Day - Glutaraldehyde Sterilizing and recall

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Why was Regimen 28 Day - Glutaraldehyde Sterilizing and recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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.

Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Recalling firm
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Quantity
31904
Distribution
AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls