—#106706

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K991301
Affected lot / code info: Lot 21X222 EXPANDED: Lot 21X221

Why it was recalled

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

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-12-09
Posted by FDA: 2012-01-17
Terminated: 2012-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106706. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.