—#159023

Product

CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K843772
Affected lot / code info: All lot numbers

Why it was recalled

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall via letter during the week on 09/25/2017.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon

Timeline

Recall initiated: 2017-09-25
Terminated: 2020-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.