Z-0602-2018Class II

ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes...

Name: Z-0602-2018 ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes...
Creator: Arrow International Inc
Published: 2017-07-25
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-07-25 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A on 2017-07-25. FDA classified it as Class II and gives the reason as "Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR...". 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-0602-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-25
Posted: 2018-02-13
Terminated: 2018-08-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.
Quantity in commerce: 2691 total
Distribution: US nationwide distribution.
Product codes and lots: Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0602-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0601-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13
Z-0602-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code LJS

K113277Class IIArrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. / cleared 2012-06-21

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)