Health product recall

RAPICIDE™ PA High Level Disinfectant

Brand(s)
Last updated

Summary

Product
RAPICIDE™ PA High Level Disinfectant
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

RAPICIDE™ PA High Level Disinfectant

689982

ML02-0116

RAPICIDE™ PA High Level Disinfectant

690994

ML02-0116

RAPICIDE™ PA High Level Disinfectant

689172

ML02-0116

RAPICIDE™ PA High Level Disinfectant

692571

ML02-0116

RAPICIDE™ PA High Level Disinfectant

691740

ML02-0116

RAPICIDE™ PA High Level Disinfectant

694358

ML02-0116

Issue

STERIS identified through customer complaints that a small number of RAPICIDE™ Part A bottles within certain lots may begin to bulge or expand over time. Part A is the active component of chemistry that creates peracetic acid, which may off-gas during the shelf-life of the product. Under routine conditions, the Part A bottle cap includes a vent intended to allow gas to escape (off-gassing) and reduce the potential for gas accumulation. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.
STERIS will provide a customer notification letter to all consignees who purchased affected lots. Consignees will be requested to follow the appropriate procedures and PPE needed to address any swollen bottles. The chemistry itself remains safe and effective to use in accordance with its labeling. However, replacement product will be provided for any product that had to be disposed.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Medivators Inc.

14605 28th Avenue North, Minneapolis, Minnesota, United States, 55447

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82643

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