Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
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.
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
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.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
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.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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
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.
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.
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.
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.
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.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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.
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.
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.
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.