W L Gore & Associates REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm recall — FDA Z-0171-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
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Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global…
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Holes in product packaging impacts package integrity and may compromise sterility.
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Firm is voluntarily recalling all lots/codes of bean and soy sprouts in commerce due to the potential for contamination with Listeria monocytogenes.
Undeclared Milk Allergen.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
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