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

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

  1. WaterLock 2

Lot or serial number
  • ASLH-F004
  • ASLH-F005
Model or catalog number

6872130

Companies
Manufacturer
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY

B. WaterLock 2 Infinity ID

Lot or serial number

ASLH-F001

Model or catalog number

6872020

Companies
Manufacturer
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY