Recall Z-0879-2008 ยท FPA Set, Administration, Intravascular
Smiths Medical MD, Inc.
Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
| Date | Feb 13, 2008 (initiated Dec 14, 2007) |
| Status | Terminated |
| Reason | Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps |
| Root cause | Process control |
| Action | Consignees were mailed the recall letters on December 21,2007. The recalled letter "Smiths Mecical Urgent Product Recall Notification" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical. |
| Quantity | 4,644 |
| Distribution | Worldwide Distribution --- USA including states of AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and countries of AN, AR, AU, BR, CA, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc., May 19, 2004 |