Class 3 Device Recall POWERWAND XL 4Fr 10cm Maximum Barrier Kit

• Date Initiated by Firm: June 15, 2020
• Create Date: July 10, 2020
• Recall Status: Terminated on October 30, 2024
• Recall Number: Z-2550-2020
• Recall Event ID: 85808
• Product Classification: Peripheral catheter insertion kit - Product Code OWL
• Product: POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.
• Code Information: Lot number 269939, 270552, 270874, and 272261.
• Recalling Firm/ Manufacturer: Access Scientific LLC; 3910 Sorrento Valley Blvd Ste 200; San Diego CA 92121-1419
• For Additional Information Contact: Martina Nguyen; 858-259-8333
• Manufacturer Reason for Recall: Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
• FDA Determined Cause: Labeling Change Control
• Action: On 06/15/2020, the firm notified affected customers via email and/or overnight mail of "URGENT: MEDICAL DEVICE RECALL" letter indicating the following: Immediately examine your inventory and quarantine product subject to correction. In addition, if you may have further distributed this product, please identify your customers and notify them a once of this product correction. Your notification to you customers may be enhanced by including a copy of this notification letter. Please take the following actions: 1. Review your inventory for the catalog and lot numbers specified in this notification and quarantine the product as appropriate. 2. You may continue to use the product specified in this notification with the understanding of the errors detailed in this notification, OR 3. Return the product specified in this notification for replacement product. 4. Complete and return the enclosed Recall Response Form as soon as possible. 5. If you choose to return the product, the firm will provide a prepaid shipping label for the return of affected product upon receipt of the Recall Response Form. 6. Report any adverse health consequences experienced with the use of this product to the firm. Events may also be reported to the Food and Drug Admirations MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions regarding this recall, please contact the firm's Senior Manager, Quality and Regulatory Affairs, via email or call 858-259-8333.
• Quantity in Commerce: 1710
• Distribution: US Nationwide distribution including in the state of NY.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.