Recalls / —

—#29838

Product

Arrow central venous catheterization kit, 14 ga x 20 cm

FDA product code

KZH — Introducer, Syringe Needle

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K862056

Affected lot / code info

Catalog number AK-04700, Lot number RF3067086

Why it was recalled

wrong product in box

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605

Distribution

Distribution pattern

The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.

Timeline

Recall initiated

2003-09-16

Posted by FDA

2003-11-01

Terminated

2004-04-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29838. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.