Z-3071-2017Class II

CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF...

Name: Z-3071-2017 CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF...
Creator: Smiths Medical ASD Inc.
Published: 2017-06-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-06-05 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2017-06-05. FDA classified it as Class II and gives the reason as "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". 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-3071-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Posted: 2017-08-25
Terminated: 2020-08-04
Recalling firm: Abbott Medical
Product: 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.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
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.
Quantity in commerce: 17280 units
Distribution: Japan, China, US
Product codes and lots: lot number 16X659

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3071-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3071-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

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)