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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1511 of 1581

Evidence Product Join Root cause
device-recall:cfres:155171 Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use Official recall number · Z-2135-2017 Process design
device-recall:cfres:155086 VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton. Official recall number · Z-2369-2017 Packaging
device-recall:cfres:155221 VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton. Official recall number · Z-2447-2017 Packaging
device-recall:cfres:154936 PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory Official recall number · Z-2127-2017 Labeling False and Misleading
device-recall:cfres:155294 VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton. Official recall number · Z-2483-2017 Packaging
device-recall:cfres:155264 VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton. Official recall number · Z-2471-2017 Packaging
device-recall:cfres:155133 VITEK¿ 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per carton. Official recall number · Z-2398-2017 Packaging
device-recall:cfres:155162 VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton. Official recall number · Z-2411-2017 Packaging
device-recall:cfres:155078 VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton. Official recall number · Z-2362-2017 Packaging
device-recall:cfres:155029 UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322. Official recall number · Z-2157-2017 Device Design
device-recall:cfres:155292 VITEK¿ 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per carton. Official recall number · Z-2482-2017 Packaging
device-recall:cfres:155870 GE Healthcare Lightspeed RT16 X-ray system Official recall number · Z-2189-2017 Software design
device-recall:cfres:155985 LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM Official recall number · Z-2624-2017 Process control
device-recall:cfres:155863 GE Healthcare LightSpeed VCT X-ray system Official recall number · Z-2183-2017 Software design
device-recall:cfres:155464 Endoscopic Introducer/Extractor Official recall number · Z-2538-2017 Labeling design
device-recall:cfres:155960 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200 Official recall number · Z-2529-2017 Packaging
device-recall:cfres:155862 GE Healthcare Optima CT660, CT680 X-ray system Official recall number · Z-2182-2017 Software design
device-recall:cfres:155727 Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature. Official recall number · Z-2288-2017 Under Investigation by firm
device-recall:cfres:154710 Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blood/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access. Official recall number · Z-2257-2017 Under Investigation by firm
device-recall:cfres:155139 Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. Official recall number · Z-2311-2017 Under Investigation by firm
device-recall:cfres:155666 Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Official recall number · Z-2539-2017 Device Design
device-recall:cfres:154708 ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. Official recall number · Z-2255-2017 Under Investigation by firm
device-recall:cfres:155740 QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Official recall number · Z-2301-2017 Under Investigation by firm
device-recall:cfres:155635 Beekley Medical 0-SPOT Mammography Skin Markers REF 652 Official recall number · Z-2309-2017 Employee error
device-recall:cfres:155732 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation Official recall number · Z-2293-2017 Under Investigation by firm

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