FDA-Device2017-09-06Class II

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.

Smiths Medical ASD Inc.
Hazard

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.

Sold states
Japan, China, US
Affected count
17280 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3071-2017

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