Recall StatusTerminated
Date Initiated2008-02-22
Date Terminated2011-01-11
Product Quantity2303
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
Firm Action
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
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.