Lack of sterility assurance for closed suction catheter systems
Avanos Medical
37 recalls • • Categories: Surgical Instruments, Other Medical Devices, Infusion Pumps
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
Lack of sterility assurance for closed suction catheter systems
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Class I - Dangerous
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class I - Dangerous
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class I - Dangerous
Incorrect expiration date.
Class I - Dangerous
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Class I - Dangerous
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Sterile extension sets were distributed without an expiration date
Class I - Dangerous
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
Class I - Dangerous
Product was distributed with incorrect expiration date.
Class I - Dangerous
Product was distributed with incorrect expiration date.
Class I - Dangerous
Product was distributed with incorrect expiration date.
Class I - Dangerous
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Class I - Dangerous
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Class I - Dangerous
Detachment of the Male AIV Adaptor from the Y-Connector.
Class I - Dangerous
Devices had cracked or detached from the feeding tube body
Class I - Dangerous
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.
Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.
Class I - Dangerous
The connector piece to the PEG tube does not pass over the guidewire.
Class I - Dangerous
The connector piece to the PEG tube does not pass over the guidewire.