—#178481

Product

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

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K163513
Affected lot / code info: REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020

Why it was recalled

Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.

Root cause (FDA determination)

Employee error

Action the firm took

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 recalls@teleflex.com. 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 recalls@teleflex.com. This will allow us to document your receipt of this letter. Adverse reactions or quality problems experienced with the us

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US: FL

Timeline

Recall initiated: 2019-12-06
Terminated: 2021-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.