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FDA Medical Device Recalls (openFDA)

Tri-State Hospital Supply Corporation: Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635.

Recall number
Z-1319-2009
Recalling firm
Tri-State Hospital Supply Corporation
Product
Tri-State Centurion Endoscopy Tray, sterile, 10 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder MNS4635.
Status
Terminated
Initiated
2009-01-14
Posted
2009-04-30
Terminated
2009-12-24
Reason
Compromised sterility, as the package seals may be inadequate.
Root cause
Packaging process control
Action
A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.
Quantity
10
Distribution
Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
Lot, serial or model codes
Lot Number: 2008111050.
510(k) numbers
not on file
PMA numbers
not on file
Product code
LRP
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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