CanadaRAPICIDE™ PA High Level Disinfectant (Medivators Inc.), model/catalogue number ML02-0116, lots 689982, 690994, 689172, 692571, 691740 and 694358 may be affected; check the lot number on your product. The recall was issued because Part A bottles can bulge from off-gassing if the vented cap is blocked, and excess vapor or liquid may escape when opening, posing a risk of user exposure and injury if PPE is not used. STERIS/Medivators will notify consignees, ask them to follow procedures and PPE for any swollen bottles, provide replacements for disposed product, and you can contact the manufacturer for more information.
What's being recalled
Companies: Medivators Inc., 14605 28th Avenue North, Minneapolis, Minnesota, United States, 55447.
How to identify it
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 689982; Model or catalogue number: ML02-0116
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 690994; Model or catalogue number: ML02-0116
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 689172; Model or catalogue number: ML02-0116
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 692571; Model or catalogue number: ML02-0116
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 691740; Model or catalogue number: ML02-0116
Affected products: RAPICIDE™ PA High Level Disinfectant; Lot or serial number: 694358; Model or catalogue number: ML02-0116
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)