Z-0837-03

SHPI LIftLoc Safety Infusion Sets

Name: Z-0837-03 SHPI LIftLoc Safety Infusion Sets
Creator: Specialized Health Products, Inc.
Published: 2003-04-17
License: https://open.fda.gov/license/

Specialized Health Products, Inc. / initiated 2003-04-17 / Terminated / root cause: packaging

FDA source

Specialized Health Products, Inc. began a recall of SHPI LIftLoc Safety Infusion Sets on 2003-04-17. The reason FDA records is "Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0837-03
Status: Terminated
Initiated: 2003-04-17
Posted: 2003-05-15
Terminated: 2003-08-20
Recalling firm: Specialized Health Products, Inc.
Product: SHPI LIftLoc Safety Infusion Sets
Product code: FPA Set, Administration, Intravascular
Reason for recall: Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.
Root cause tag: packaging
FDA root cause: Other
Action: The single consignee (BAS) was notified by lettter on 4/14/03.
Quantity in commerce: 2240 units
Distribution: Utah.
Product codes and lots: Product Code - Lot #: 0661934- 36ANHP01; 0662034 - 36ANHP02; 0662234 - 36ANHO03; 0661910 -36ANHP04; 0661915 - 36ANHP04; 0661915 -36ANHP06; 0662015 - 36ANHO7; 0662215 -36ANHP08; 0662010- 36ANHP09; 0641910 -36ANHP10; 0642234 -36ANHP11; 0642210 - 36ANHP12; 0641934 -36ANHP13; 0642034 -36ANHP14; 0642010 -36ANHP15; 0614915 -36ANHP16; 0642015 -36ANHP17; 0642210 -36ANHP19; 0642234 -36ANHP20; 0641910 -36ANHP21.

Product code FPA

K013394Class IILiftloc Safety Infusion SetSpecialized Health Products, Inc. / cleared 2001-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)