FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
- Recall number
- Z-0823-06
- Recalling firm
- Haemonetics Corporation
- Product
- Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
- Status
- Terminated
- Initiated
- 2005-12-21
- Posted
- 2006-04-29
- Terminated
- 2008-03-12
- Reason
- Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
- Root cause
- Other
- Action
- Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .
- Quantity
- 151 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial Numbers: 05F022-1; 05F023-1; 05H103;05C083-05C084; 05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;05D060-05D068;05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1; 05E055-1; 05E056;05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072; 05F098-05F107;05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-05G059; 05G080-05G084;05H018; 05H022; 05H024- 05H027; 05H073-05H077; 05H100-05H101; 05H104; 05H163; 05J185-05J189; 05K011-05K013; 05K015--05K017; 05K092-05K096; 05K168-05K173 ; 05K175; 05K201
- 510(k) numbers
- ["K014083"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 1219343
- Firm city
- Braintree
- Firm state
- MA
- 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