Date Issued: January 5, 2016
Health Care Providers in Puerto Rico
Staff working at Health Care Facilities or Hospitals in Puerto Rico
Product: Customed surgical convenience packs and trays contain instruments and other items that are used during surgical procedures, including general hospital, dental, and obstetrical and gynecological procedures.
Surgical convenience packs include items such as exam gloves, absorbent towels, suture bags, surgical table covers and drapes. Surgical trays include additional items such as sodium chloride irrigation bottles, catheters, needles and syringes.
The FDA is warning health care providers and staff at health care facilities not to use Customed convenience packs and trays for any surgical procedures. The integrity, safety and efficacy of these products cannot be assured because adequate testing has not been completed to assure:
- The sterility of the products,
- That endotoxin and ethylene oxide levels are within safe limits,
- That package integrity can withstand stresses during transport, and
- That the products will be effective up to their expiration dates.
These deficiencies pose a risk of serious adverse health consequences, such as infection and death.
Summary of Problem and Scope:
Medical devices and supplies used in surgery must be kept clean and germ-free (sterile) to prevent patient infections. Customed initiated a voluntary recall of its surgical convenience packs on June 3, 2014 due to potentially compromised sterility caused by the plastic packaging of one unit sticking to adjacent units during the sterilization process. When separated, the packaging could tear, allowing microorganisms to enter and contaminate the contents.
An FDA inspection of Customed’s manufacturing facilities in July 2014 disclosed deficiencies concerning the validation of the sterilization process and packaging design. The FDA sent a Warning Letter to the firm on December 9, 2014, confirming the deficiencies found during the inspection.
Customed initiated a second voluntary recall on October 8, 2014, that expanded the previous recall and added surgical convenience trays. The FDA classified both recalls as Class I because the lack of assurance of product sterility, and package integrity, posed a high risk of serious adverse health consequences.
From October 8, 2014 to November 21, 2014, the firm stopped distributing products. In November 2014, they resumed manufacturing without informing the FDA. In early 2015, the FDA became aware that Customed had resumed manufacturing of these products but had not made the necessary corrections required to do so. Additionally, the Puerto Rico Hospital Supply company was distributing these products in Puerto Rico.
A follow-up inspection of the firm was conducted from April 6-29, 2015 to determine the status of the corrective actions performed. This inspection found that the corrective actions specific to ethylene oxide (EO) sterilization validation and package integrity testing were still inadequate and incomplete.
In particular, the Agency learned that Customed did not verify through testing that its sterile products have:
- Acceptable low levels of endotoxin, a toxin that is released upon destruction of the bacterial cells after EO sterilization, or,
- Acceptable low levels of EO residue, a toxin that remains after EO sterilization.
By not verifying the levels of these substances through testing, Customed cannot assure the safety and efficacy of the devices.
In July 2015, Customed issued additional recalls for products distributed between November 21, 2014 and June 23, 2015, due to continued issues with validation of the sterility and packaging of contents in the convenience packs and trays. Additionally, Customed could not verify the integrity of products after transport or until the listed expiration date.
Due to persistent concerns with products still in distribution, the FDA recommends customers not use these products.
Recommendations for Health Care Providers:
The FDA recommends health care providers stop using Customed surgical convenience packs and trays for all surgical procedures until their safety has been verified. Use of these products could potentially expose patients to serious adverse health consequences, such as infection and death.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you suspect or experience a problem with Customed’s Surgical Convenience Packs or Trays, please file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@cdrh.fda.gov or 800-638-2041.
- Customed Inc. Press Release issued August 21, 2014
- Customed Inc. Press Release issued November 21, 2014