FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case
- Recall number
- Z-1831-2008
- Recalling firm
- Atrium Medical Corporation
- Product
- HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case
- Status
- Terminated
- Initiated
- 2008-05-12
- Posted
- 2008-08-14
- Terminated
- 2009-08-20
- Reason
- Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
- Root cause
- Nonconforming Material/Component
- Action
- Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.
- Quantity
- 21 cases (10 individual/case)
- Distribution
- Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
- Lot, serial or model codes
- Lot #s 10304311, 10321933, 10336423
- 510(k) numbers
- ["K912645"]
- PMA numbers
- not on file
- Product code
- GBS
- Firm FEI
- 3011175548
- Firm city
- Hudson
- Firm state
- NH
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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