Recalls / —

—#153690

Product

Manometer, 550 ml three-Way Stopcock; STERILE;

FDA product code

KRK — Manometer, Blood-Pressure, Venous

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962

Why it was recalled

The integrity of the sterile packaging is potentially compromised.

Root cause (FDA determination)

Package design/selection

Action the firm took

On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.

Recalling firm

Firm

Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Timeline

Recall initiated

2017-02-23

Terminated

2019-07-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #153690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.