—#87460

Product

Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous access and catheter introduction to the central circulation.

FDA product code: KGZ — Accessories, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K781846
Affected lot / code info: Catalog number: ASK-09903-CMC, Lot number RF9060715

Why it was recalled

Some central venous catheter sets had the incorrect lid stock.

Root cause (FDA determination)

Packaging

Action the firm took

Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- MA.

Timeline

Recall initiated: 2009-12-15
Posted by FDA: 2010-05-05
Terminated: 2011-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87460. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.