Recall Z-0987-2009 ยท FPA Set, Administration, Intravascular
Smiths Medical MD, Inc.
CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.
| Date | Apr 20, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due |
| Root cause | Process control |
| Action | An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to |
| Quantity | 17,868 cassettes (1,489 boxes 12 cassettes/box) |
| Distribution | Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843772 | CADD-1 5100 AMBULATORY INFUSION PUMP Deltec Systems, Inc., Dec 6, 1984 |