Z-0876-2008

Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24...

Name: Z-0876-2008 Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24...
Creator: Smiths Medical MD, Inc.
Published: 2007-12-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-12-14 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical MD, Inc. began a recall of Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St... on 2007-12-14. The reason FDA records is "Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps". 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-0876-2008
Status: Terminated
Initiated: 2007-12-14
Posted: 2008-02-13
Terminated: 2011-01-11
Recalling firm: Abbott Medical
Product: Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
Product code: FRN Pump, Infusion
Reason for recall: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were mailed the recall letters on December 21,2007. The recalled letter "Smiths Mecical Urgent Product Recall Notification" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical.
Quantity in commerce: 317,532
Distribution: Worldwide Distribution --- USA including states of AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and countries of AN, AR, AU, BR, CA, CL, CN, CZ, DK, EE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IT, JO, JP, KW, LB, MY, NL, NO, PA, PL, PT, SA, SE, SG, TAIWAN, TH, VI, ZA, CH, AT, and BE.
Product codes and lots: 030X17/035/043/049/050/053/056/066/070/072/079/083/087/091/094/104-106.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)