AVID Medical, Inc.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that can trigger immune reactions in patients. The affected kits were distributed nationwide to surgical facilities.

AVID Medical is recalling 70 different neurological and spine surgical kits that contain Ritmed Neurological Sponges. The sponges may have unexpected variability in endotoxin levels, which could affect their safety and sterility during surgical use.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that could trigger an immune response if present at higher-than-expected levels. About 11,763 kits across multiple surgical specialties are affected.

Certain Halyard STANDARD LINE INSERTION PACK kits (Model PVHM234-01) have a defect in the silicone seal that may not seal properly. This defect can cause the seal to dome inward, potentially blocking fluid flow or allowing fluid to leak where it shouldn't.

Certain Halyard EYE PACK convenience kits (Model LVEY27) contain Betadine solution at an incorrect concentration. The kits were distributed nationwide, primarily in California. No injuries have been reported.

AVID Medical, Inc. distributed 60 kits of Halyard Eye Bag Pack (Kit Code UIEB48-01) with sealed pouches that did not undergo validated sterilization. The affected kits were distributed nationwide in Iowa. No injuries have been reported.

Halyard Drape Pack kits (Code LMDP36-01) were distributed without proper sterilization validation. Approximately 72 kits shipped with sealed pouches that had not undergone the required sterilization process. These kits were distributed nationwide and in Iowa.

AVID Medical inadvertently distributed 224 kits of Halyard Towel Six Pack (Kit Code AMTS70-01) with sealed pouches that had not undergone validated sterilization. The affected kits were distributed nationwide, with concentration in Iowa. No injuries have been reported.

AVID Medical distributed 120 sealed Halyard Pain Pack kits (Kit Code AMPK48-01, Lot 334669) that did not undergo proper sterilization validation. The affected kits were distributed nationwide, with known distribution in Iowa. No injuries have been reported.

Halyard TRANSPORT BAG KIT (Kit Code LIFE0080-01) may have a defective Tyvek bag seal that could compromise the sterility of the kit. The issue affects approximately 1,500 units distributed in New Jersey. No injuries have been reported.

AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.

Halyard's ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) is not suitable for organ transplant procedures. The FDA has classified this as a Class I recall, the most serious type. A total of 52 units were distributed in Florida, Georgia, and Puerto Rico.

Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15) devices have been found to be unsuitable for organ transplant use. The FDA has issued a Class I recall affecting 132 units distributed in Florida, Georgia, and Puerto Rico. No injuries have been reported.

AVID Medical is recalling Halyard HEAD AND NECK TRAY (Catalog Number EURO016-09) due to a potential incomplete seal on the header bag. This affects 56 units distributed in Georgia, Illinois, Nebraska, and Maryland. An incomplete seal could compromise the sterility or integrity of the surgical tray.

AVID Medical is recalling Halyard Major Pack surgical kits (Catalog Number JEMJ10-01) because the header bag seal may not close completely. This affects 90 units distributed to Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

AVID Medical is recalling Halyard arteriogram kits (Catalog Number EUHM009-01) because the header bag may not seal completely. This could allow the sterile contents inside to become contaminated. The recall affects 300 units distributed to hospitals in Georgia, Illinois, Nebraska, and Maryland.

AVID Medical is recalling Halyard EP LAB PK sterile field packs (Catalog Number ESJH009-03) because the header bag may not seal completely during sterilization. An incomplete seal could allow bacteria or other contaminants to enter the sterile package before use. This affects 240 units distributed to hospitals and medical facilities in Georgia, Illinois, Nebraska, and Maryland.

Halyard's General Laparoscopy Pack (catalog number VAST018-10) may have an incomplete seal on its header bag, which could compromise the sterility of the surgical instruments inside. This affects 42 units distributed to hospitals and surgical centers in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.