Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the followi
FDA device recall Z-0993-2011 · posted 2011-02-04 · Terminated
Recall details
- Recalling firm
- Arstasis, Inc
- Reason for recall
- Device has the potential to fracture and sheath separation during use.
- Action taken
- 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 customerservice@arstasis.com. If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 330 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-10-19
- Date posted
- 2011-02-04
- Date terminated
- 2011-02-16
- Location
- Redwood City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARSTASIS ACCESS SYSTEM (K102728) | Arstasis, Inc. | 2010-10-07 |
| ARSTASIS ACCESS SYSTEM (K100615) | Arstasis, Inc. | 2010-03-30 |
| ITG VASCULAR ACCESS SYSTEM, MODEL 300 (K091006) | Arstasis, Inc. | 2010-02-25 |