Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
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.
Labeled as a 48mm Cortical Screw but measuring at 50mm
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.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
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.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.