Estados Unidos Recalls

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463

Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

Power Over Fiber Base Module

Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

IQon Spectral CT IQon Spectral CT Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

Victory Medical Center Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds

Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system

Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

M5 Corpus Power Wheelchair REF,120032

This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances.

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.