Recall Z-0993-2011 ยท DYB Introducer, Catheter
Arstasis, Inc
Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous intro
| Date | Feb 4, 2011 (initiated Oct 19, 2010) |
| Status | Terminated |
| Reason | Device has the potential to fracture and sheath separation during use. |
| Root cause | Device Design |
| Action | The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to |
| Quantity | 330 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |