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U.S. Department of Health and Human Services

Class 2 Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224

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 Class 2 Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224 see related information
Date Posted August 30, 2007
Recall Status1 Terminated on February 10, 2011
Recall Number Z-1215-2007
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, 100 ml PC
4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA


Code Information 081X16, 082X16, 085X16, 088X16, 089X16, 090X16, 091X16, 094X16, 095X16, 096X16, 097X16, 104X16, 105X16, 106X16, 107X16, 109X16, 110X16, 112X16, 113X16, 115X16, 119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16, 136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16, 157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16, 169X16, 170X16, 171X16, 172X16, 173X16, 176X16, 177X16, 179X16, 182X16, 183X16, 186X16, 187X16, 189X16, 190X16, 192X16, 195X16, 196X16, 199X16, 200X16, 203X16, 204X16, 206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16, 216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16, 229X16
Recalling Firm/
Manufacturer
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-628-7280
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
Other
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 113,143
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.
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