Class I Medical Device Recall: Customed Inc., Surgical Convenience Packs

By Effective Medicine  On  In Medical Devices Tagged  


Recall Class:  Class I

Date Recall Initiated:  June 3, 2014

Product(s):  Multiple Surgical Packs.See complete listing of affected products.

Lot numbers: All lots manufactured between January 9, 2009 and May 20, 2014 are affected.

Use: Each pack contains instruments or other items that are used during a surgical procedure.

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

Reason for Recall: Surgical pack sterility may be compromised due to individual packs adhering to one another inside the shipping case.  In some cases, the plastic packaging of one bag (along the printed words “SNAP SMARTLY TO OPEN”) has adhered to the end seal of an adjacent pack.  When the bags are separated, the plastic film can tear and compromise the sterility of the contents.

There is significant risk of compromised sterility and use of a contaminated product, whether the package is damaged or not.  The products have been exposed to uncontrolled and inadequate storage conditions and there are serious deficiencies in the manufacturing process. 

The use of affected product may cause serious adverse health consequences, such as infection and death.

Public Contact:  Customers who have questions may reach the Customed Recall Coordinator at 787-622-5151, extension 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 outlined the problem and the 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 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.


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