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U.S. Department of Health and Human Services

Class 2 Device Recall Reserve, Cassette, CADD, 100ml, yellow, mdl 2100, 21710024

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 Class 2 Recall
Reserve, Cassette, CADD, 100ml, yellow, mdl 2100, 21710024
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Date Posted August 30, 2007
Recall Status1 Open
Recall Number Z-1213-2007
Recall Event ID 38306
Premarket Notification
510(K) Number
K843772 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
Code Information 083X16, 084X16, 116X16, 131X16,137X16, 140X16, 146X16, 151X16, 162X16, 185X16, 198X16, 224X16, 225X16
Recalling Firm/
Manufacturer
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Consumer Instructions Contact the recalling firm for information
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 Affected Cassettes have been used for delivering Flolan.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 8555 boxes
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = DELTEC SYSTEMS, INC.
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