Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for
FDA device recall Z-0895-2015 · posted 2014-12-30 · Terminated
Recall details
- Recalling firm
- Atricure Inc
- Reason for recall
- Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
- Action taken
- AtriCure sent an Urgent Recall Notification letter dated November 21, 2014 with Acknowledgement Form to all affected customers. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to notify their customers at once of this product recall. Customers were instructed to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. For any questions, call the toll-free Recall Hotline (844-783-5302), M-F, 8:00 AM-8:00 PM EST.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 19,190 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JA
- Date initiated
- 2014-11-21
- Date posted
- 2014-12-30
- Date terminated
- 2015-07-20
- Location
- West Chester, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRICURE CRYO1 CRYO-ABLATION PROBE (K082074) | AtriCure, Inc. | 2009-03-02 |