Z-3071-2017 Class II Terminated
FDA device recall Z-3071-2017 was initiated by Smiths Medical ASD Inc. on June 5, 2017 and is designated Class II. Reason for recall: 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 route… The recall status is terminated (terminated August 4, 2020). Affected quantity: 17280 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- June 5, 2017
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17280 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Japan, China, US
Code Information
lot number 16X659