Z-1494-2014Class II

Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally...

Name: Z-1494-2014 Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally...
Creator: Arrow International Inc
Published: 2014-03-24
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-03-24 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter on 2014-03-24. FDA classified it as Class II and gives the reason as "Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter". 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-1494-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-24
Posted: 2014-04-24
Terminated: 2015-09-21
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "
Quantity in commerce: 789
Distribution: Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca
Product codes and lots: lot #23F14A0375

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code LJS

K121941Class IIArrow Picc Powered by Arrow Vps StyletArrow International (Subsidiary of Teleflex Inc.) / cleared 2012-09-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)