Recalling Firm / Manufacturer

Smiths Medical MD, Inc.

Product

Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA

Code Information

102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16, 194X16, 202X16, 205X16, 226X16

Reason of Recall

Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering Flolan.

Date Recall Initiated

June 18, 2007

Action

All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.