COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order recall — FDA Z-1775-2026
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or…
Contains undeclared egg, soy, and hazelnut
Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Potential Salmonella Contamination
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