CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, i
FDA device recall Z-1641-2008 · posted 2008-08-24 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their Pump, there is a potentia
- Action taken
- A "Smith Medical Urgent Medical Device Correction" letter dated February 22, 2008 was distributed to consignees. The letter addressed to Risk/Safety Managers, Distributors, Clinicians, Patients and other Customers, instructs them to fully tighten the battery cap and to routinely monitor the pump for damage that may result in power down situations. Consignees are to return the "Urgent Medical Device Correction" form. If you have questions about the letter or did not received the letter contact Mike Herbert at 651-628-7049 or Jeff Esselman at 651-628-7920.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2303
- Distribution
- AZ CA FL GA HI IL KY MD MI MN NC NE NJ NM NY PA TN TX UT CANADA CHILE CZECH REPUBLIC GERMANY GREAT BRITAIN ITALY JAPAN NETHERLANDS NORWAY SWEDEN
- Date initiated
- 2008-02-22
- Date posted
- 2008-08-24
- Date terminated
- 2011-01-11
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-MS 3 AMBULATORY INFUSION PUMP (K051568) | Smiths Medical MD, Inc. | 2005-11-17 |