Z-1194-2018Class II

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Name: Z-1194-2018 ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Creator: Arrow International Inc
Published: 2017-12-15
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-12-15 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B on 2017-12-15. FDA classified it as Class II and gives the reason as "Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1194-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-03-14
Terminated: 2019-07-18
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.
Quantity in commerce: 305
Distribution: Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
Product codes and lots: Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1194-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code FOZ

K151513Class IIArrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) / cleared 2015-07-08

MDM coverage of this record lists here, newest first.

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)