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Showing 2641–2660 of 8389 results

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Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

FDAJul 23, 2024Nationwide• Unomedical A/S Osted Aholmvej 1

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Sevoflurane E_Vap.(Safety Filling adapter) used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

SlideView VS200 slide viewer, (EVIDENT SCIENTIFIC INC) – a broken fuse inside the laser that w... (2024)

A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.

FDAJul 22, 2024Nationwide• EVIDENT SCIENTIFIC INC

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Isoflurane E_Vap.(Safety Filling adapter): used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

BioButton REF BIOST06040 with Software version 3.0.20 Th... (Biointellisense Inc. 570 El Camino Real) – software anomaly causing the skin tem... (2024)

Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

FDAJul 19, 2024CA, CO, MA +2 more• Biointellisense Inc. 570 El Camino Real

ClotTriever XL Catheter, 30 mm, REF: 41-102, used with In... (Inari Medical Oak Canyon) – laceration hazard (2024)

Laceration Risk

Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.

FDAJul 19, 2024Nationwide• Inari Medical Oak Canyon

smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHE... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure f... (Becton Dickinson & Co.) – may intermittently produce falsely re... (2024)

May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.

FDAJul 18, 2024Nationwide• Becton Dickinson & Co.

Flexima APDL Drainage Catheter System and Kit, Material N... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

prodisc C SK, Total cervical disc replacement, medical d... (Centinel Spine, Inc.) – during the assembly of prodisc c, a b... (2024)

During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

FDAJul 18, 2024Nationwide• Centinel Spine, Inc.

smiths medical portex, 15mm Double Swivel Connector: a... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

Flexima Regular Kit Biliary Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

smiths medical portex, Nasopharyngeal Airway, Sizes as fo... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

smiths medical portex, Y' PIECE 15MM, REF 100/276/000 (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)

Uncertainty in the seal integrity of the sterile packaging.

FDAJul 18, 2024Nationwide• Smiths Medical ASD Inc.

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Cathe... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

VTC Regular Kit Nephrostomy Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

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