Recall Z-0775-2012 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD, Inc.
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
| Date | Jan 17, 2012 (initiated Dec 9, 2011) |
| Status | Terminated |
| Reason | 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 | Mixed-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 addit |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 Sims Deltec, Inc., Jun 9, 1999 |