Z-1213-2007

Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100...

Name: Z-1213-2007 Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100...
Creator: Smiths Medical MD, Inc.
Published: 2007-06-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-06-18 / Terminated

FDA source

Smiths Medical MD, Inc. began a recall of Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in... on 2007-06-18. The reason FDA records is "Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1213-2007
Status: Terminated
Initiated: 2007-06-18
Posted: 2007-08-30
Terminated: 2011-02-10
Recalling firm: Abbott Medical
Product: Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
Product code: FPA Set, Administration, Intravascular
Reason for recall: Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.
FDA root cause: Other
Action: All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.
Quantity in commerce: 8555 boxes
Distribution: Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.
Product codes and lots: 083X16, 084X16, 116X16, 131X16,137X16, 140X16, 146X16, 151X16, 162X16, 185X16, 198X16, 224X16, 225X16

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