Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI; Reord

FDA device recall Z-1321-2009 · posted 2009-04-30 · Terminated

Recall details

Recalling firm

Tri-State Hospital Supply Corporation

Reason for recall

Compromised sterility, as the package seals may be inadequate.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

KDD

Quantity affected

140

Distribution

Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.

Date initiated

2009-01-14

Date posted

2009-04-30

Date terminated

2009-12-24

Location

Howell, MI