—#99000

Product

Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780532
Affected lot / code info: Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936

Why it was recalled

Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.

Root cause (FDA determination)

Other

Action the firm took

The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: USA including states of: PA and NJ.

Timeline

Recall initiated: 2011-03-25
Terminated: 2014-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.