Recalls / —

—#53166

Product

Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K033290

Affected lot / code info

414371,414372,414373,433069,433070,453469,453470,453471,488549,488550,488551,488552,488553,488554,

Why it was recalled

The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

Root cause (FDA determination)

Other

Action the firm took

Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical.

Recalling firm

Firm

ICU Medical, Inc.

Address

951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern

VA, OH, TX, CA, GA

Timeline

Recall initiated

2006-09-26

Posted by FDA

2007-08-16

Terminated

2012-03-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #53166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.