AUDIENCE: Risk Manager, Surgery
ISSUE: The FDA is warning health care providers and staff at health care facilities in Puerto Rico 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.
BACKGROUND: See the FDA Safety Communication for descriptions of previous Customed recalls.
RECOMMENDATION: 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.
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.
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form 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
[01/05/2016 - Safety Communication - FDA]