Z-1705-2017Class II

The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein

Name: Z-1705-2017 The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein
Creator: Arrow International Inc
Published: 2017-03-03
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-03-03 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein on 2017-03-03. FDA classified it as Class II and gives the reason as "Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads...". 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-1705-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2017-03-08
Terminated: 2018-02-27
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.
Quantity in commerce: 1,351 catheters
Distribution: US Distribution
Product codes and lots: Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-03

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)