Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems
Monday, December 29, 2014
Recall Class: Class I
Date Recall Initiated: October 8, 2014
Devices: Surgical Convenience
Packs, Trays, and Bags (known as Convenience Packs)
Class I Recall Notice.
- Complete listing of recalled devices
- Manufacturing dates: November 1, 2001 to October 7, 2014
- Distribution dates: November 2011 to October 9, 2014
Use: Each pack contains tools
or other items that are used during surgery.
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
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:
About Class I Recalls
- Stop using the products
- Remove the product from inventory and stop distribution
- Return the acknowledgement the form enclosed with the “Urgent
- Notify any customers who may have received the product through
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.
Source: U.S. Food and Drug Administration (FDA) (Accessed: