Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
FDA Recall Z-1029-04 · Posted 2004-07-20
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Recalling FirmHorizon Medical Products Inc
Recall StatusTerminated
Product CodeKOC
Date Initiated2004-05-28
Date Terminated2005-01-12
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.
Firm Action
Consignees were notified via letter on 5/28/2004.
Root Cause
Other
Distribution Pattern
AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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