Recalls / —

—#93308

Product

MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters

FDA product code

DYB — Introducer, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K002507

Affected lot / code info

Product # AK-11142-B, Lot # RF0033311

Why it was recalled

Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern

The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.

Timeline

Recall initiated

2010-07-29

Posted by FDA

2010-09-25

Terminated

2012-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #93308. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.