Scissors, General, Surgical（LRW）

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Reports of various packaging issues that may result in a breach of the sterile barrier.

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.

The sterile barrier may be compromised.

The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.