Gauze/sponge, Internal

Brand Name: Pilling Wecksorb

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Ritmed Neurological Sponges, Description/REF:

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Pilling Wecksorb Cylindrical Sponges

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE)

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges.

Gauze sponges contained in custom kits may be flaking or fraying.