Lumen Peripherally Insert Central Catheter Kits (2017-01-16)

Starting date:

January 16, 2017

Posting date:

February 9, 2017

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-62124

• Reason
• Affected products

Affected Products

1. Single-Lumen Peripherally Inserted Central Catheter Kit
2. Two-Lumen Peripheraly Inserted Central Catheter Kit
3. Picc Seldinger Conversion Set

Reason

Arrow International has received complaints for peel away sheaths flaring. The instructions for use included in the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. The use of a skin nick reduces the probability of sheath flare and subsequent complications. There is a remote possibility the device may cause a delay in treatment or minor vessel wall trauma and bleeding.

Affected products