The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.
Medical Action Industries, Inc. 306
19 recalls • • Categories: Infusion Pumps, Surgical Instruments, Other Medical Devices
Class I - Dangerous
The kits contain saline flush syringes which were recalled by the supplier.
Class I - Dangerous
Scissors contained debris.
Class I - Dangerous
XXX
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Class I - Dangerous
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Class I - Dangerous
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Class I - Dangerous
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.