ORS DRAPES (2015-08-26)

Starting date:

August 26, 2015

Posting date:

September 29, 2015

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-55100

• Reason
• Affected products

Recalled Products

1. ORS FLUID WARMING DRAPE
2. ORS SLUSH DISC DRAPE
3. ORS SLUSH/WARMER DISC DRAPE

Reason

The reason for recall is that the sterile packaging may contain small channels in the seal of the pouch. If channels are present, the package integrity is compromised and there exists a remote chance that a non-sterile drape may be used during a surgical procedure.

This issue was discovered during routine internal testing. No reports of patient injury or complaints have been received as a result of this issue. Ecolab conducted a health risk assessment and determined the chance of serious adverse health consequences (infection) to be extremely unlikely.

Affected products