🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Ultroid Technologies
🏥 Medical Devices Class I - Dangerous
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
🏥 Medical Devices Class I - Dangerous
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Stanmore Implants Worldwide
🏥 Medical Devices Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Zeus-P Lumbar Interbody Device
Amendia
🏥 Medical Devices Class I - Dangerous
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.