FDA Medical Device Recalls

Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 17, 2024

Power Express, REF B90918

Reason: The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

Root cause: Nonconforming Material/Component

Recalling firm: Beckman Coulter Biomedical GmbHType: Radioassay, Vitamin B12Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.Recall #Z-2978-2024

Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 17, 2024

PE Centrifuge, REF: B36365, a component of the Power Express

Reason: The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

Root cause: Nonconforming Material/Component

Recalling firm: Beckman Coulter Biomedical GmbHType: Radioassay, Vitamin B12Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.Recall #Z-2979-2024

Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 17, 2024

PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

Reason: The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

Root cause: Nonconforming Material/Component

Recalling firm: Beckman Coulter Biomedical GmbHType: Radioassay, Vitamin B12Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.Recall #Z-2980-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 1, 2024

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Reason: A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

Root cause: Process control

Recalling firm: Fresenius Kabi USA, LLCType: Set, Administration, IntravascularDistribution: US Distribution to states of: CO, ID, NJ, UT.Recall #Z-2721-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Jul 22, 2024

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

Reason: 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

Root cause: Nonconforming Material/Component

Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: CanadaRecall #Z-2949-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Jul 22, 2024

Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00

Reason: 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

Root cause: Nonconforming Material/Component

Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: CanadaRecall #Z-2950-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Jul 22, 2024

Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00

Reason: 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

Root cause: Nonconforming Material/Component

Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: CanadaRecall #Z-2951-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Jul 22, 2024

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00

Reason: 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

Root cause: Nonconforming Material/Component

Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: CanadaRecall #Z-2952-2024

Open, ClassifiedPosted Sep 4, 2024·Initiated Aug 6, 2024

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.