Sterilant, Medical Devices

STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

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

Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid

Certain lots of the acid solution in Acecide-C are degrading faster than normal.

CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060

During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.

The SYSTEM 1E Liquid Sterilant Processing System.

The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

QKC1692E

STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manu

The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.