Class I - Dangerous
Surgical drape packs may have open seals, which may compromise the sterility of the product.
O&M HALYARD
7 recalls • • Categories: Infusion Pumps, Other Medical Devices, Surgical Instruments
Class I - Dangerous
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class I - Dangerous
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class I - Dangerous
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class I - Dangerous
Product was mislabeled as a Surgical Cap at its dispenser level.
Class I - Dangerous
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Class I - Dangerous
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.