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 Recall Z-3071-2017 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-06-05
Date Terminated2020-08-04
Product Quantity17280 units
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.
Firm Action
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.
Root Cause
Process change control
Distribution Pattern
Japan, China, US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.