WaterLock 2 and WaterLock 2 Infinity ID (2018-10-11)

Starting date:

October 11, 2018

Posting date:

November 15, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68208

• 
  Reason
• 
  Affected products

Affected products

1. WaterLock 2
2. WaterLock 2 Infinity ID

Reason

The diaphragms in a number of the "WaterLock 2" (6872130) and "WaterLock 2 Infinity ID" (6872020) water traps in the affected lots were fitted the wrong way around.

This can shorten the lifespan of the water trap and thus result in a failure of the measurement - possibly after just a few hours of operation, depending on the humidity content of the breathing gas. The anaesthetic gas monitoring will detect the failure of the measurement and will alert users by giving an appropriate technical alarm. In this case the water trap will need to be replaced.

Affected products