Z-1286-2015Class II

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only

Name: Z-1286-2015 CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only
Creator: Smiths Medical ASD, Inc.
Published: 2015-02-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-02-02 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only on 2015-02-02. FDA classified it as Class II and gives the reason as "Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1286-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-02
Posted: 2015-03-17
Terminated: 2016-03-18
Recalling firm: Abbott Medical
Product: CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
FDA root cause: Under Investigation by firm
Action: Smiths Medical sent an "Urgent Medical Device Recall" letter dated February 2, 2015, to all affected customers. The letter was addressed to Risk Safety Manger, Biomedical Professionals, Clinicians who oversee the use of CADD pumps, Distributors, and other users of these devices. The letter described the problem and the product involved in the recall. The letter also addressed the "Advice on Action to be Taken by the User", and "Transmission of this Urgent Recall Notice". Customers were requested to complete and return the Confirmation Form by Fax to 1-800-237-8033 or be email to recall.response@smiths-medical. For issues with these products they can contact Smiths Medical's Global Complaint Department at 1-866-216-8806 or [email protected]. For questions on the information provided they can contact Customer Service Department at 1-800-258-5361.
Quantity in commerce: 48,208 (17,040 US, 31,168 OUS).
Distribution: Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, Denmark, Spain. Finland, France, United Kingdom (GB) Hungary, Indonesia, Ireland, Italy, Netherlands, Portugal, Sweden, Singapore and South Africa.
Product codes and lots: 21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1286-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1286-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-17

Product code FPA

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)