Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.Reason: Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
Distributed: Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UKReason: Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
Distributed: Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UKReason: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Distributed: Worldwide Distribution and USA Nationwide.Reason: RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
Distributed: Distributed to Florida.Reason: Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.
Distributed: Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.Reason: Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
Distributed: USA (nationwide)