Arrow Pressure Injectable Multi Lumen CVC Kit (2019-01-07)

Starting date:

January 7, 2019

Posting date:

January 23, 2019

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-68900

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  Reason
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  Affected products

Affected products

Arrow Pressure Injectable Multi Lumen CVC Kit

Reason

Arrow International is recalling the product due to a labeling error.

The lot (13F17J0444) is product code ASK-42703-PRJ so it should contain a 3-lumen, 7 Fr x 16 cm catheter. However, the product may be incorrectly labeled as ASK-45703-PRJ.  In this case, the pre-printed lidstock states it contains a 3-lumen, 7 Fr x 20 cm catheter. There is an additional label on the lidstock outlining the correct part number ASK-42703-PRJ. The package contains a 3-lumen, 7 Fr x 16 cm catheter.

The incorrect catheter length would not likely cause any serious health consequence; however, it may lead to a minor delay in completion of the procedure. No patient injuries have been reported related to this issue.

Affected products