Z-1910-2008

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

Name: Z-1910-2008 USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units...
Creator: Medical Components, Inc dba MedComp
Published: 2008-04-11
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2008-04-11 / Terminated

FDA source

Medical Components, Inc dba MedComp began a recall of 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... on 2008-04-11. The reason FDA records is "kit contains incorrect component". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1910-2008
Status: Terminated
Initiated: 2008-04-11
Posted: 2008-09-16
Terminated: 2008-10-28
Recalling firm: Medical Components, Inc.
Product: 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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: kit contains incorrect component
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 250 units
Distribution: The products were shipped to customers in PA and TX.
Product codes and lots: Lot number MAPA880

Product code LJS

K053345Class IIPro-Line CT Power Injectable Cvc, Models Ctlines5s, Ctline6dMedcomp / cleared 2006-03-17

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)