Medline Industries Recalls

Hazard: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

Hazard: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

Hazard: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

Hazard: Convenience kits labeled as sterile have not gone through the sterilization process.

Hazard: Convenience kits labeled as sterile have not gone through the sterilization process.

Hazard: Subpotent drug

Hazard: Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit

Hazard: Defective Container: Customer complaints for leaking bottles and dispensing issues.

Hazard: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Hazard: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Hazard: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Hazard: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Hazard: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Hazard: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

Hazard: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

Hazard: The kits may contain an expired component.

Hazard: The kits may contain an expired component.

Hazard: The kits may contain an expired component.

Hazard: The kits may contain an expired component.

Hazard: Potential for mold contamination (Aspergillus vadensis)

Hazard: The devices may not meet the minimum required sterility assurance level.

Hazard: Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

Hazard: Possible false negative or false positive results due to the product being compromised during shipment.

Hazard: Product was compromised during shipment.

Hazard: Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

Hazard: The cylindrical sponge component is not x-ray detectable.

Hazard: The cylindrical sponge component is not x-ray detectable.

Hazard: The cylindrical sponge component is not x-ray detectable.

Hazard: The cylindrical sponge component is not x-ray detectable.

Hazard: The cylindrical sponge component is not x-ray detectable.