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.
Recall
- Recall Number
- Z-2288-2020
- Event Number
- 85645
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- BSO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 8, 2020
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
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.
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
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 [email protected]. 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 [email protected]. 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.
US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
109 eaches (US), 23,021 (OUS)