Caresite Luer Access Device (2013-10-15)

Starting date:

October 15, 2013

Posting date:

October 28, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36403

• Reason
• Affected products

Recalled products

A. Caresite Luer Access Device 

Reason

B. Braun Medical inc. (BBMI) has identified the instruction for use (IFU) on the Caresite Luer Access Device (Product 415128) exhibits translated instructions in the incorrect section and/or partially missing translation instructions. Specifically, the French section is primarily Spanish and the Spanish section is primarily Italian. It should be noted, all other content information including the warning section is translated correctly and accurate on the IFU. At this time, no patient harm or adverse impact has been noted as a result of this issue.

Affected products