FDA Medical Device Recalls (openFDA)
Tri-State Hospital Supply Corporation: Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.
- Recall number
- Z-1571-2009
- Recalling firm
- Tri-State Hospital Supply Corporation
- Product
- Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.
- Status
- Terminated
- Initiated
- 2008-04-08
- Posted
- 2009-07-07
- Terminated
- 2009-11-19
- Reason
- The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
- Root cause
- Material/Component Contamination
- Action
- Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
- Quantity
- 100 kits
- Distribution
- Indiana, Mississippi, Ohio and Tennessee.
- Lot, serial or model codes
- Kit lots 802188 and 802198. Heparin flush lot 7113064.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OKE
- Firm FEI
- 1824619
- Firm city
- Howell
- Firm state
- MI
- 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