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.
Recall
- Recall Number
- Z-3071-2017
- Event Number
- 77555
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- June 5, 2017
- Terminated
- August 4, 2020
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
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.
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.
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.
Japan, China, US
17280 units