Medical Devices Recalls

Hazard: Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.

Hazard: Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Hazard: Due to complaints of device breakage at the traction force gauge to handle joint.

Hazard: There is a possibility of reagent leakage from the specimen container.

Hazard: Product does not have FDA clearance.

Hazard: Cyber vulnerability of BLE communication was found by CISA VDP program.

Hazard: Cyber vulnerability of BLE communication was found by CISA VDP program.

Hazard: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Hazard: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

Hazard: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Hazard: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Hazard: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Hazard: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

Hazard: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Hazard: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Hazard: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Hazard: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Hazard: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Hazard: Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

Hazard: Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Hazard: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Hazard: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Hazard: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Hazard: X-Ray generator may malfunction resulting in the X-Ray being inoperable.