Z-0837-2020Class II

Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

Name: Z-0837-2020 Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Creator: Arrow International Inc
Published: 2019-12-06
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-12-06 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH on 2019-12-06. FDA classified it as Class II and gives the reason as "Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH". 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-0837-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-06
Posted: 2020-01-22
Terminated: 2021-11-02
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On December 6, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Recall Notice Arrow Endurance" Extended Dwell Peripheral Catheter System EIF-000391 December 06, 2019 To: Customer of Arrow Products Arrow International is voluntarily recalling the following product code and lots: Product Code: ASK-00820-FLH Lot Numbers: 13F19E0247, 13F19F0006, 13F19G0433 Arrow International is recalling the above product code and lots due to a potential sterility issue. The product was processed through the incorrect sterilization cycle; thus, the sterility of the device cannot be guaranteed. If the devices sterility is compromised and the product is used it could lead to infectious complications. No complaints, patient injuries or deaths have been reported at this time. Our records indicate you have received products that are subject to this action. We are now notifying our customers to take the following actions: 1. Inspect your inventory for the affected product codes above. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or 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 Teleflex Medical. 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. Adverse reactions or quality problems experienced with the us
Quantity in commerce: 575
Distribution: US: FL
Product codes and lots: REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0837-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-22

Product code FOZ

K163513Class IIArrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) / cleared 2017-02-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)