PR.com: Business Directory, Press Releases, Jobs, Products, Services, Articles
 
Businesses Articles Press Releases Follow @PRcom
Press Release Pricing | News by Category | News by Country | News by US Region | Recent News | PR.com News on Your Site
 

Press Releases

 

Customed

Press Release


Receive press releases from Customed: By Email PDF Version RSS Feeds:
Customed, Inc. Issues Recall of Sterile Convenience Surgical Packs

Fajardo, PR, August 22, 2014 --(PR.com)-- On June 3rd, 2014 Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014.

Customed’s convenience sterile surgical packs are used primarily in hospitals or medical offices for surgical interventions such as: Anesthesiology; Arthroscopy; Cardiovascular; Dental, Ear, Nose, and Throat (ENT); Gastroenterology and Urology; General and Plastic Surgery; General Hospital; Neurology; Obstetrical and Gynecological; Ophthalmic; and Orthopedic procedures.

Consumers who have products should stop using the product lots included 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: January 9, 2009 to May 19, 2014
· Distribution Dates: January 2009 to May 2014

The firm voluntarily recalled the products after becoming aware of the adhesion defect through Customed 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 & Panama; and South America-Colombia).

Consumers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at 1-787-801-0100 Ext. 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 MedWatch Adverse Event Reporting program either online, by regular mail or by fax.Complete and submit the report Online: www.fda.gov/medwatch/report.htm1

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 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

Customed, Inc.
Igualdad Ave. Final #7
Fajardo, Puerto Rico 00738
www.customedhealing.com
Contact Information
Customed
Mr. Hector Agosto
787-801-0100
Contact
Attached Files
Customed Product Catalogs and Lot Numbers.
Filename: PRESSRELEASE.txt

Click here to view the list of recent Press Releases from Customed
Promote Your Business