FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F
- Recall number
- Z-0499-03
- Recalling firm
- Haemonetics Corporation
- Product
- Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F
- Status
- Terminated
- Initiated
- 2002-12-17
- Posted
- 2003-01-30
- Terminated
- 2016-01-28
- Reason
- Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Root cause
- Other
- Action
- Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
- Quantity
- 3368
- Distribution
- Nationwide Canada
- Lot, serial or model codes
- JJ02014 KK02001 KK02010 KK02015 KK02018 KK02022 KK02026 LL02004 LL02006 LL02020
- 510(k) numbers
- ["K932890"]
- 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