Terminated

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 Recall Z-0060-2018 · Posted None

Recalling FirmSmiths Medical ASD Inc.

Recall StatusTerminated

Product CodeFRN

Date Initiated2017-09-25

Date Terminated2020-08-07

Product Quantity2827352 units

Reason for Recall

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

Firm Action

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

Root Cause

Process control

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K843772CADD-1 5100 AMBULATORY INFUSION PUMPDeltec Systems, Inc. · 1984-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.