—#82830

Product

Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K862056
Affected lot / code info: Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.

Why it was recalled

The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.

Root cause (FDA determination)

Process design

Action the firm took

Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.

Timeline

Recall initiated: 2009-06-17
Posted by FDA: 2009-07-07
Terminated: 2009-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.