Recalls / —

—#30027

Product

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

FDA product code

KZH — Introducer, Syringe Needle

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K924607

Affected lot / code info

Catalog/Model number CL-07011, Lot number CF03075226

Why it was recalled

package lid identifies the contents incorrectly

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

Timeline

Recall initiated

2003-10-22

Posted by FDA

2003-11-01

Terminated

2004-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.