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U.S. Department of Health and Human Services

Class 2 Device Recall Reserve, Cassette, CADD, 50ml, mdl 2050P, 21700124

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  Class 2 Device Recall Reserve, Cassette, CADD, 50ml, mdl 2050P, 21700124 see related information
Date Initiated by Firm June 18, 2007
Date Posting Updated August 30, 2007
Recall Status1 Terminated 3 on February 10, 2011
Recall Number Z-1214-2007
Recall Event ID 38306
510(K)Number K843772  
Product Classification Medication Cassette Reservoir - Product Code FPA
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
Recalling Firm/
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Quantity in Commerce 32,100
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = DELTEC SYSTEMS, INC.