Recall Z-0060-2018 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
| Date | Sep 25, 2017 |
| Status | Terminated |
| Reason | Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. |
| Root cause | Process control |
| Action | The firm initiated the recall via letter during the week on 09/25/2017. |
| Quantity | 2827352 units |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, |
| 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 |