Atlas FDA

Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufac

FDA device recall Z-1030-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Horizon Medical Products Inc
Reason for recall
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
Action taken
Consignees were notified via letter on 5/28/2004.
Root cause
Other
Status
Terminated
Product code
KOC
Distribution
AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
Date initiated
2004-05-28
Date posted
2004-07-20
Date terminated
2005-01-12
Location
Manchester, GA

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