Z-0104-06

Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4

Name: Z-0104-06 Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
Creator: Medical Components, Inc dba MedComp
Published: 2005-09-15
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2005-09-15 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4 on 2005-09-15. The reason FDA records is "The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0104-06
Status: Terminated
Initiated: 2005-09-15
Posted: 2005-10-28
Terminated: 2005-11-22
Recalling firm: Medical Components, Inc.
Product: Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
Quantity in commerce: 88 units
Distribution: The products were shipped to distributors in OH and MO.
Product codes and lots: Lot number MABY950

Product code LJS

K003682Class IIMedcomp Z-CathMedical Components, Inc. / cleared 2001-01-26

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)