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
This recall has been terminated (originally issued August 30, 2007).
- Company
- Smiths Medical Md, Inc.
- Recall Initiated
- June 18, 2007
- Posted
- August 30, 2007
- Terminated
- February 10, 2011
- Recall Number
- Z-1214-2007
- Quantity
- 32,100
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for 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.
Distribution
Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.
Lot / Code Info
102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16, 150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16, 194X16, 202X16, 205X16, 226X16
Root Cause
Other
Action Taken
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.