Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented s
FDA device recall Z-0878-2008 · posted 2008-02-13 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 78, 792
- 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
- Date initiated
- 2007-12-14
- Date posted
- 2008-02-13
- Date terminated
- 2011-01-11
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-1 5100 AMBULATORY INFUSION PUMP (K843772) | Deltec Systems, Inc. | 1984-12-06 |