Recalls / —

—#161618

Product

Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

FDA product code

DQY — Catheter, Percutaneous

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K862056

Affected lot / code info

Lot number: 13F17C0501

Why it was recalled

These finished good kits may contain the incorrect Springwire Guide (SWG).

Root cause (FDA determination)

Process control

Action the firm took

On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

Distribution US Nationwide

Timeline

Recall initiated

2017-10-17

Posted by FDA

2018-02-20

Terminated

2020-04-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161618. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.