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Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits
The FDA is aware that AVID Medical has issued letters to affected customers recommending certain Organ Recovery OR Packs and Medical Convenience kits be corrected prior to continued use.
AVID Medical stated that the 24x30 Poly bags included in the Organ Recovery Packs are not medical grade poly and are not suitable for organ transplant. In addition, the plastic bags may not be sealed on the bottom. The compromised integrity of the bag could result in a lack of containment of the donor organ during use. AVID Medical has reported a lack of containment instance.
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact AVID Medical at complaints@owens-minor.com
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