Z-0207-2016Class II

ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure...

Name: Z-0207-2016 ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure...
Creator: Arrow International Inc
Published: 2015-10-16
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2015-10-16 / Terminated

FDA source

Arrow International Inc began a recall of ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC... on 2015-10-16. FDA classified it as Class II and gives the reason as "Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0207-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-16
Posted: 2015-11-04
Terminated: 2017-11-09
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology 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. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
FDA root cause: Unknown/Undetermined by firm
Action: Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact consignees with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. For consignees with no affected product, should also complete the enclosed Recall Acknowledgement Form. For questions customers should call 1-866-246-6990.
Quantity in commerce: 12,157
Distribution: World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.
Product codes and lots: Product Codes ASK-45552-RWJ3 CDC-35541-HPK1A EU-00750-45 PL-00750 AU-00420-MAJO CDC-35541-VPS EU-02041-ML PL-00755 CDC-34041-HPK1A CDC-35552-HPK1A EU-24041-HPMSB PR-35552-HPHNM CDC-34041-VPS CDC-35552-VPS EU-24052-HPMSB PR-45563-HPHNM CDC-34052-HPK1A CDC-41563-JX1A EU-25041-HPMSB UK-00420-MID CDC-34052-VPS CDC-44041-HPK1A EU-25052-HPMSB UK-00420-RCHT CDC-35041-HPK1A CDC-44052-HPK1A EU-25063-HPMSB UK-00420-THT CDC-35041-VPS CDC-44063-HPK1A EU-25541-HPMSB UK-04041-RDEH CDC-35052-HPK1A CDC-45063-HPK1A EU-25552-HPMSB UK-05041-MSB CDC-35052-VPS CDC-45563-HPK1A IB-01652 UK-05041-RDEH CDC-35063-HPK1A EU-00740-45 PL-00740 UK-05052-RCHT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0207-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04

Product code LJS

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)