U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
조치
Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable).
All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products.
All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect.
Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.