News & Press: Patient Safety

Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems

Monday, December 29, 2014  
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Recall Class: Class I

Date Recall Initiated: October 8, 2014

Devices: Surgical Convenience Packs, Trays, and Bags (known as Convenience Packs)
  • Complete listing of recalled devices
  • Manufacturing dates: November 1, 2001 to October 7, 2014
  • Distribution dates: November 2011 to October 9, 2014
See Related Class I Recall Notice.

Use: Each pack contains tools or other items that are used during surgery.

Recalling Firm:
Customed, Inc.
Calle Igualdad Final #7
Fajardo, Puerto Rico 00738

Reason for Recall: Tools and other items used in surgery must be kept very clean and germ-free (sterile) to prevent patient infections. These surgical convenience packs may not be sterile because there were problems with how they were made and stored by the manufacturer before they were sent to customers. The use of the recalled product may cause health consequences for the patient, such as infection and death.

Public Contact: Customers who have questions may reach the Customed Recall Coordinator at 1-787-622-5151, extension 7111 or 7510, Monday through Friday, 8:00 a.m. - 5:00 p.m., Eastern Time

FDA District:  San Juan District Office

More Information about this Recall:
Customed has sent several “Urgent Recall Notification” letters to their customers. The letter informed customers of the expansion of the previous recall and steps to be taken.

Customers who have this product in their inventory should:
  • Stop using the products
  • Remove the product from inventory and stop distribution
  • Return the acknowledgement the form enclosed with the “Urgent Recall Notification”
  • Notify any customers who may have received the product through re-distribution.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Resources
    Source: U.S. Food and Drug Administration (FDA) (Accessed: 12/29/2014)

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