Recall Z-3071-2017 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
| Date | Jun 5, 2017 |
| Status | Terminated |
| Reason | The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly. |
| Root cause | Process change control |
| Action | Consignees (may include distributors and hospitals) in Japan were notified the week of June 5, 2017. Recall letters were delivered by Smiths Medical, Japan sales representatives during the week of 06/19/2017. The consignees were directed to return any affected devices in their possession and receive replacements. Their Smiths Medical sales representative will collect the affected product and replacement product will be sent to them. |
| Quantity | 17280 units |
| Distribution | Japan, China, US |
| 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 |