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U.S. Department of Health and Human Services

Class 2 Device Recall CADD High Volume Administration Set

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 Class 2 Recall
CADD High Volume Administration Set
see related information
Date Posted January 17, 2012
Recall Status1 Terminated on November 06, 2012
Recall Number Z-0775-2012
Recall Event ID 60883
Premarket Notification
510(K) Number
K991301 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product CADD® High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to allow fluid delivery from an IV bag. EXPANDED: Catalog No./ REF 21-7381-01
Code Information Lot 21X222 EXPANDED: Lot 21X221
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Manufacturer Reason
for Recall
Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical became aware that an additional Product Reorder No. 21-738-01 and Lot No. 21X221 are also being recalled for receiving reports regarding occlusion/high pressure alarms with the use of these set
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Consignees were sent a Smiths Medical "Urgent Field Safety Notice" letter dated January 04, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Distributors and other users of these devices. The letter described the details on affected devices, Advise on Action to be Taken by the User and distributor and Transmission of this Urgent Field Safety Notice. Requested consignees to inspect their inventory and remove affected product and to complete and return the attached Confirmation Form. EXPANDED: The additional devices were distributed 12/14/2011 thru 1/27/2012. An Urgent Medical Device letter, dated 3/16/2012, was sent to customers beginning 3/16/2012. The letter identified the additional affected product, described what the issue is and asked that customers return all unused sets to Smiths Medical for credit or replacement. Also, the customer was asked to complete and return an Urgent Medical Device Recall Confirmation Form. If the customer is a distributor, they were asked to pass along the information to their customers.
Quantity in Commerce 5,385 EXPANDED 16,125 devices
Distribution Nationwide Distribution -- AZ, CA, FL, GA, IL, KS, LA, ME, MA, NC, OR, PA,SC, TX, VA, WA, and WI. EXPANDED to include AR, CO, IA, IN, MD, MI, MN, MO, NJ, OH, OK, TN, WV and Canada.
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 = SIMS DELTEC, INC.
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