Access Scientific LLC Recalls
Showing 1-2 of 2 recalls
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.
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits.