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.
Recall
- Recall Number
- Z-2550-2020
- Event Number
- 85808
- Firm
- Access Scientific LLC
- FEI Number
- 3009549229
- Product Code
- OWL
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- June 15, 2020
- Terminated
- October 30, 2024
- Address
- 3910 Sorrento Valley Blvd, Ste 200, San Diego, CA, 92121-1419
Description
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.
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.
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.
US Nationwide distribution including in the state of NY.
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