Z-2771-2016Class II

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base...

Name: Z-2771-2016 Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base...
Creator: Arrow International Inc
Published: 2016-02-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-02-17 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components on 2016-02-17. FDA classified it as Class II and gives the reason as "Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products". 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-2771-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Posted: 2016-09-09
Terminated: 2017-10-18
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to [email protected], even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 6,121 units in total
Distribution: US Distribution to states of: NC, OH, FL, and MD.
Product codes and lots: Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2771-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2771-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09
Z-2772-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09
Z-2773-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09
Z-2774-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code LJS

K061289Class IIArrow Pressure Injectable PiccArrow International, Inc. / cleared 2006-08-24

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)