Z-0060-2018Class II

CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For...

Name: Z-0060-2018 CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For...
Creator: Smiths Medical ASD Inc.
Published: 2017-09-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-09-25 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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)... on 2017-09-25. FDA classified it as Class II and gives the reason as "Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0060-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-25
Posted: 2017-11-01
Terminated: 2020-08-07
Recalling firm: Abbott Medical
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).
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall via letter during the week on 09/25/2017.
Quantity in commerce: 2827352 units
Distribution: 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
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0060-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0060-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-11-01
Z-0061-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-11-01
Z-0062-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-08	2017-11-01

Product code FRN

K843772Class IICadd-1 5100 Ambulatory Infusion PumpDeltec Systems, Inc. / cleared 1984-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)