FDA Medical Device Recalls (openFDA)
Spire Biomedical, Inc.: 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free
- Recall number
- Z-0327-2010
- Recalling firm
- Spire Biomedical, Inc.
- Product
- 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free
- Status
- Terminated
- Initiated
- 2009-10-23
- Posted
- 2009-11-17
- Terminated
- 2010-06-09
- Reason
- There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
- Root cause
- Process control
- Action
- Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
- Quantity
- 26 units
- Distribution
- Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- ["K032061","K040509","K042858","K060155","K063431","K063441"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 1000159376
- Firm city
- Bedford
- 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