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FDA Medical Device Recalls (openFDA)

Tri-State Hospital Supply Corporation: Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.

Recall number
Z-1574-2009
Recalling firm
Tri-State Hospital Supply Corporation
Product
Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.
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
140 trays
Distribution
Indiana, Mississippi, Ohio and Tennessee.
Lot, serial or model codes
Tray lots 801148, 810297 and 812187. Heparin flush lot 7041194.
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
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

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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

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