Recalls / —
—#156494
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.
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K843772
- Affected lot / code info
- lot number 16X659
Why it was recalled
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 (FDA determination)
Process change control
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Japan, China, US
Timeline
- Recall initiated
- 2017-06-05
- Terminated
- 2020-08-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #156494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.