Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Class I - Dangerous
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Sunquest Information Systems
Class I - Dangerous
In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."
Class I - Dangerous
Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
Class I - Dangerous
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Distal part of the anchor may break on insertion into bone during surgery
Class I - Dangerous
ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Distal part of the anchor may break on insertion into bone during surgery
During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone.
Class I - Dangerous
Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Distal part of the anchor may break on insertion into bone during surgery
Class I - Dangerous
ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Philips Healthcare
Class I - Dangerous
When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
Class I - Dangerous
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
Class I - Dangerous
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Class I - Dangerous
Digital Skin Mammography Marker separating from the backing of the spot material