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USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and i

FDA device recall Z-1910-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm
Medical Components, Inc dba MedComp
Reason for recall
kit contains incorrect component
Action taken
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
Status
Terminated
Product code
LJS
Quantity affected
250 units
Distribution
The products were shipped to customers in PA and TX.
Date initiated
2008-04-11
Date posted
2008-09-16
Date terminated
2008-10-28
Location
Harleysville, PA

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Related 510(k) clearances

RecordFirmDate
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D (K053345)Medcomp2006-03-17