There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
A nonsterile component was packaged in a sterile convenience kit.
Potential for the tip of the electrode to detach during use.
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
Kits were packed into shipping boxes incorrectly.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Recalled devices were packaged in convenience kits.
Products are mislabeled with the incorrect product identification on individual kit labeling.
Kits lacks rubber latex warning label.
The kit contains a non-sterile needle.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Gauze sponges contained in custom kits may be flaking or fraying.
Labeling error, incorrect expiration date.
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.