Z-2331-2017Class II

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with...

Name: Z-2331-2017 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with...
Creator: Arrow International Inc
Published: 2017-05-09
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-05-09 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic... on 2017-05-09. FDA classified it as Class II and gives the reason as "Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2331-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-12
Terminated: 2018-09-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution: Worldwide Distribution - US (nationwide) and Canada
Product codes and lots: Material number: ASK-45552-RWJ4 Device Listing D213817

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2331-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2328-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2329-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2330-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2331-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2332-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2333-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2334-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2335-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2336-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2337-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12
Z-2338-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-12

Product code LJS

K112896Class IIArrw EvolutionArrow International (Subsidiary of Teleflex Inc.) / cleared 2012-05-10

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)