Z-0987-2009

CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF...

Name: Z-0987-2009 CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF...
Creator: Smiths Medical MD, Inc.
Published: 2008-12-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-12-09 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical MD, Inc. began a recall of CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette... on 2008-12-09. The reason FDA records is "Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette...". 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-0987-2009
Status: Terminated
Initiated: 2008-12-09
Posted: 2009-04-20
Terminated: 2012-06-07
Recalling firm: Abbott Medical
Product: CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to [email protected] (in US) or [email protected] (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.
Quantity in commerce: 17,868 cassettes (1,489 boxes 12 cassettes/box)
Distribution: Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.
Product codes and lots: Lot Numbers 213X18 and 214X18.

Product code FPA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)