USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system.
FDA Recall Z-1910-2008 · Posted 2008-09-16
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJS
Date Initiated2008-04-11
Date Terminated2008-10-28
Product Quantity250 units
Reason for Recall
kit contains incorrect component
Firm Action
The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
Root Cause
Mixed-up of materials/components
Distribution Pattern
The products were shipped to customers in PA and TX.
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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