RecallRadar

FDA Device recall Z-0061-2018

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except…

On 2017-11-08 the FDA classified a Class II recall of CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except… by Smiths Medical Asd, citing smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0061-2018
ClassificationClass II
Statusterminated
Initiated2017-09-25
Published2017-11-08
Last updated2026-09-13 11:54 UTC
CompanySmiths Medical Asd
DistributionUS

Product

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, 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).

Reason

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

Identifiers

code_infoAll lot numbers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0061-2018%22

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