Recalls / —

—#35142

Product

Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP

FDA product code

LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K930129

Affected lot / code info

Lot numbers RF4088610 and RF4088406

Why it was recalled

Product was mislabeled for lumen configuration, flow rates, and priming volume.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

The products were shipped to hospitals in AZ, CA, NJ, and WV.

Timeline

Recall initiated

2004-09-21

Posted by FDA

2005-02-18

Terminated

2005-05-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.