FDA Medical Device Recalls (openFDA)
Specialized Health Products, Inc.: SHPI LIftLoc Safety Infusion Sets
- Recall number
- Z-0837-03
- Recalling firm
- Specialized Health Products, Inc.
- Product
- SHPI LIftLoc Safety Infusion Sets
- Status
- Terminated
- Initiated
- 2003-04-17
- Posted
- 2003-05-15
- Terminated
- 2003-08-20
- Reason
- Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.
- Root cause
- Other
- Action
- The single consignee (BAS) was notified by lettter on 4/14/03.
- Quantity
- 2240 units
- Distribution
- Utah.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K013394"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3000214919
- Firm city
- Bountiful
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28