Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arterioven
FDA device recall Z-2312-2013 · posted 2013-09-30 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
- Action taken
- Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at returns@atriummed.com
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- DYF
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Eg
- Date initiated
- 2013-07-12
- Date posted
- 2013-09-30
- Date terminated
- 2014-07-15
- Location
- Hudson, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANTA SUPER SOFT GRAFT (K000504) | Atrium Medical Corp. | 2000-03-01 |