205 recalls tagged with “laceration risk”.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
This recall involves EnHomee Fabric 13-Drawer Dressers. The Fabric 13-Drawer Dressers are 55.12" W x 35.45" H x 11.02" D and come in rustic brown, white, black, and pink.
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Possible presence of stones in product
Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.