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

Date of Recall

2014-11-25

Recall Details

- November 21, 2014 - Fajardo, Puerto Rico - On October 8^th, 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.

No serious injuries or deaths have been reported as of October 9^th, 2014. The FDA believes that it is unlikely that any infections that have occurred would be attributed to the Convenience Kits and consequently adverse events might be underreported.

Customed Convenience Kits are used primarily in hospitals or medical offices for patient care, wound healing, removal of sutures, etc. as well as in a wide range of surgical procedures.

Consumers who have products should stop using the product lots contained in the tables below.

Customed, Inc. is:

• Notifying its distributors by mail
• Arranging for the products return (after the included response form is completed)
• Requiring distributors to notify any customers who received the product through redistribution.

Affected Products Information:

• The recall includes the product catalogs and lot numbers in the table below.
• Manufacturing Dates: November 1^st, 2011 to October 7^th, 2014
• Distribution Dates: November 2011 to October 9^th, 2014

Customed has voluntarily recalled these products after becoming aware of potential defects through its Quality System and has notified the FDA of this action.

Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America-Costa Rica).

Consumers with questions about this recall may contact Customed Recall Coordinator, at 1-787-622-5151 Ext. 7111 or 7540, Monday through Friday, 8:00 a.m. - 5:00 p.m., Eastern Time. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Med Watch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Product Lot Information

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