—#95621

Product

Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. Permits venous access to the central circulation.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Lot/Serial Number: CF9065974.

Why it was recalled

One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit.

Root cause (FDA determination)

Process control

Action the firm took

The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: International Distribution Only -- Argentina and Columbia.

Timeline

Recall initiated: 2010-11-09
Posted by FDA: 2011-01-12
Terminated: 2012-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.