FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: Haemonetics Cell Saver 5 Fast Pack List Number: 260
- Recall number
- Z-0498-03
- Recalling firm
- Haemonetics Corporation
- Product
- Haemonetics Cell Saver 5 Fast Pack List Number: 260
- 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
- 15,150
- Distribution
- Nationwide Canada
- Lot, serial or model codes
- JJ02013 JJ02016 JJ02019 JJ02020 KK02002 KK02004 KK02005 KK02006 KK02007 KK02008 KK02013 KK02016 KK02017 KK02019 KK02021 KK02023 KK02025 LL02002 LL02005 LL02007 LL02008 LL02010 LL02011 LL02013 LL02014 LL02016 LL02017 LL02021 LL02023 LL02024 MM02001 MM02002 MM02003 MM02004 MM02005 MM02006
- 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