Customed, Inc. Issues Recall of Sterile Convenience Kits-Trays, Bags, and New Lots Added to the Previous Recall

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

Customed, Inc. Issues Recall of Sterile Convenience Kits-Trays, Bags, and New Lots Added to the Previous Recall

11/25/2014 12:03 PM EST

On October 8th, 2014 Customed, Inc. initiated a recall of sterile convenience surgical kits-trays, bags (known as "Convenience Kits"), and New Lots Added as follow-up to the June 3, 2014 Class I recall of 233 sterile convenience surgical kits. The Convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? Please visit subscriberhelp.govdelivery.com
• Other inquiries? webmail@oc.fda.gov

---

This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420