Class 2 Device Recall Arrow FlexTip Plus Epidural Kit with NRFit Connector

• Date Initiated by Firm: May 08, 2020
• Create Date: June 05, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2288-2020
• Recall Event ID: 85645
• 510(K)Number: K140110
• Product Classification: Catheter, conduction, anesthetic - Product Code BSO
• Product: Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US); OT19TAGSK; OT19TAGSKA; OT19TAPSK; OT19TCGLK; ; Product Codes (OUS); AT-05501-NRF; OT19HBPSS; UM-05400-NRF; ASK-05500-NRON; EJ-05400-NRON; OU-05500-NRON; TU-05500-NRON; ; The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
• Code Information: Lots: (Dist'd in US) 23F19A0260 23F19M0224 23F19E0120 23F19L0014 23F19B0184 (Dist'd OUS) 71F19M0710 71F18K1579 71F18F1429 71F18J2111 71F20A1078 71F20A1614 71F19E2019 71F19L0269 71F19L2068 71F19K1049 71F19K2042 71F19L0977 71F19M1319 71F20A0805 71F20A0812 71F20A0813 71F19J0604 71F19K1653 71F19K2501 71F19M0326 71F20A1819 71F20A2040 71F20A0044 71F19K2043 71F19L0359
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Customer Service; 866-396-2111
• Manufacturer Reason for Recall: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
• FDA Determined Cause: Under Investigation by firm
• Action: On May 8, 2020, the firm distributed "Urgent Medical Device Recall" letters to affected customers. The letter informed customers that the product was being recalled due to complaints reporting that the rotatable collar on the filter had detached, causing a leak. If a leak presents during use, an alternative filter may be required, or the catheter may need to be removed and replaced with a new kit. Customers are asked to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of the Urgent Medical Device Recall Notice or to return product, complete the included Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm 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 the firm to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 109 eaches (US), 23,021 (OUS)
• Distribution: US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BSO and Original Applicant = TELEFLEX, INC.