Z-2025-2018Class II

Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS...

Name: Z-2025-2018 Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS...
Creator: Arrow International Inc
Published: 2018-04-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-04-11 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS... on 2018-04-11. FDA classified it as Class II and gives the reason as "Product sterility may be compromised due to unsealed packaging". 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-2025-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Posted: 2018-05-30
Terminated: 2020-05-15
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Product sterility may be compromised due to unsealed packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.
Quantity in commerce: 416,055 total products
Distribution: US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Product codes and lots: Lot Numbers: Product code: PR-44041-BAS: 13F17F0101 PR-44052-BAS: 13F17F0103 13F17K0128 PR-44063-BAS: 13F17F0104 13F17K0129 PR-45041-BAS: 13F17F0105 13F17K0241 PR-45052-BAS: 13F17F0106 13F17K0236 PR-45063-BAS: 13F17J0203 13F17K0471 PR-45541-BAS: 13F17F0107 PR-45541-HPHNL: 13F17A0165 13F17D0327 13F17G0008 13F17H0416 13F17H0572 13F17K0238 13F17L0049 PR-45541-HPHNM: 13F17B0174 13F17C0188 13F17E0738 13F17G0006 PR-45552-BAS: 13F17F0108 13F17K0237 PR-45552-HPHNL: 13F17C0467 13F17E0017 13F17E0758 13F17F0523 PR-45552-HPHNM: 13F17B0178 13F17C0469 13F17E0120 13F17G0412 13F17H0393 13F17J0172 13F17L0335 PR-45563-BAS: 13F17F0109 PR-45563-HPHNL: 13F17C0354 13F17D0341 13F17J0402 PR-45563-HPHNM: 13F17L0688

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1958-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1959-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1960-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1961-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1962-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1963-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1964-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1965-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1966-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1967-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1968-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1969-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1970-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1971-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1972-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1973-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1974-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1975-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1976-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1977-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1978-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1979-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1980-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1981-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1982-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1983-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1984-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1985-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1986-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1987-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1988-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1989-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1990-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1991-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1992-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1993-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1994-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1995-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1996-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1997-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1998-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-1999-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2000-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2001-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2002-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2003-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2004-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2005-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2006-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2007-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2008-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2009-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2010-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2011-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2012-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2013-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2014-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2015-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2016-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2017-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2018-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2019-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2020-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2021-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2022-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2023-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2024-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2025-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2026-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2027-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2028-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2029-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2030-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2031-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30
Z-2032-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30

Product code LJS

K130876Class IICg+ Arrow Picc Powered by Arrow Vps StyletArrow International, Inc. / cleared 2013-04-26

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)