Smiths CADD Medication Cassette Reservoirs with Clamp and… recallZ-0876-2008 · Smiths Medical MD, Inc. · initiated Dec 14, 2007
Terminated All recalls posted in February 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical MD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0876-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2007
- Posted by the FDA
- Feb 13, 2008
- Recalling firm
- Smiths Medical MD, Inc.
- Quantity
- 317,532
- Product code
- FRN
- FDA submissions
- K843772
- 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 description
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
Code information (models, lots, serial numbers)
030X17/035/043/049/050/053/056/066/070/072/079/083/087/091/094/104-106.
Other devices under the same FDA submission
3 devices cleared under K843772 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-7002-24Icu Medical, Inc. · Pump, infusion1 recall331 reports
- CADD 21-7001-24Icu Medical, Inc. · Pump, infusion2 recalls100 reports
- CADD 21-7100-24Icu Medical, Inc. · Pump, infusion1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 46288).
- Z-0877-2008 · TerminatedSmiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
- Z-0878-2008 · TerminatedSmiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 551…
- Z-0879-2008 · TerminatedSmiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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