Device product
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.
Z-3071-2017
Product summary
- Event
- Event 77555
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17280 units
- Official record key
device-enforcement:Z-3071-2017
Official wording
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.
Code information: lot number 16X659
Distribution pattern: Japan, China, US
Derived failure modes
-
Unknown
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.