Z-1366-2019Class II

Arrow PICC powered by Arrow VPS Precision Stylet

Name: Z-1366-2019 Arrow PICC powered by Arrow VPS Precision Stylet
Creator: Arrow International Inc
Published: 2018-12-13
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-12-13 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or... on 2018-12-13. FDA classified it as Class II and gives the reason as "Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1366-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-13
Posted: 2019-05-16
Terminated: 2020-10-01
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Arrow International initiated recall notification letter on 13th December 2018 via FedEx 2-day mail describing problem ,health risk and action to take:, immediately discontinue use and quarantine the products. Complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
Quantity in commerce: 963 units (US) in total
Distribution: US Nationwide Distribution
Product codes and lots: Lot/Batch Number: 23F18B0581 GTIN:20801902120704

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1366-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1365-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1366-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-16

Product code LJS

K153487Class IICG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) / cleared 2016-02-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)