FDA Device

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Hazard

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

What You Should Do

Remedy

Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

Products

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to
Brand
Arrow International Inc
UPC
Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC,   Device Listing D025180

Units Affected

27, 485 distributed in the U.S, 4,371 distributed Internationally