Smiths Medical MD, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Smiths Medical MD, Inc.
Lot Codes / Batch Numbers
102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16, 194X16, 202X16, 205X16, 226X16
Products Sold
102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16, 194X16, 202X16, 205X16, 226X16
Smiths Medical MD, Inc. is recalling Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 5 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026