EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat
FDA device recall Z-0111-2013 · posted 2012-10-22 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction initiated is to provide the recommend
- Action taken
- Ethicon sent a notification letter "Urgent Product Information EVICEL Fibrin Sealant (Human) All Lots and Product Codes" dated June 27, 2012, to all affected customers. Notifications were sent via UPS on July 2, 2012. The notification informed customers of the identified risks and included instructions for use. The notification included a business reply card consignees were requested to fill out and return. Customer were notified by a notification titled "Urgent Product Information Omrix Pressure Regulator All Product Codes" that was sent by Ethicon on August 1, 2012, as a follow up to the letter dated June 27, 2012. The notification informed consignees of the identified risks and included instructions for use. Customers were notified that a company representative would visit them to confirm receipt of the notification and to ensure the enclosed label has been affixed correctly on all Omrix Pressure Regulators. For further questions please call 1-877-384-4266.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 4800 pressure regulators distributed worldwide; 1500 distributed within the US
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
- Date initiated
- 2012-07-02
- Date posted
- 2012-10-22
- Date terminated
- 2015-09-15
- Location
- Somerville, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVICEL APPLICATION DEVICE (K090162) | Omrix Biopharmaceuticals , Ltd. | 2009-02-20 |