Atlas FDA

SHPI LIftLoc Safety Infusion Sets

FDA device recall Z-0837-03 · posted 2003-05-15 · Terminated

Recall details

Recalling firm
Specialized Health Products, Inc.
Reason for recall
Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.
Action taken
The single consignee (BAS) was notified by lettter on 4/14/03.
Root cause
Other
Status
Terminated
Product code
FPA
Quantity affected
2240 units
Distribution
Utah.
Date initiated
2003-04-17
Date posted
2003-05-15
Date terminated
2003-08-20
Location
Bountiful, UT

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Related 510(k) clearances

RecordFirmDate
LIFTLOC SAFETY INFUSION SET (K013394)Specialized Health Products, Inc.2001-11-08