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Recall Observatory FDA recall evidence

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Device recall evidence

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

Indexed record set

39,516 evidence rows

Page 1514 of 1581

Evidence Product Join Root cause
device-recall:cfres:148909 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. Official recall number · Z-2808-2016 Process control
device-recall:cfres:145892 Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Official recall number · Z-2611-2016 Unknown/Undetermined by firm
device-recall:cfres:148236 Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five. Official recall number · Z-2537-2016 Material/Component Contamination
device-recall:cfres:145895 Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Official recall number · Z-2614-2016 Unknown/Undetermined by firm
device-recall:cfres:148325 Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable Official recall number · Z-2563-2016 Process control
device-recall:cfres:147876 Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V). Official recall number · Z-2602-2016 Process design
device-recall:cfres:148303 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable Official recall number · Z-2555-2016 Process control
device-recall:cfres:147493 TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. Official recall number · Z-2582-2016 Under Investigation by firm
device-recall:cfres:147491 TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. Official recall number · Z-2581-2016 Under Investigation by firm
device-recall:cfres:148670 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves Official recall number · Z-2544-2016 Process control
device-recall:cfres:147496 TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. Official recall number · Z-2585-2016 Under Investigation by firm
device-recall:cfres:148141 Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Official recall number · Z-2354-2016 Other
device-recall:cfres:148532 SMR allen wrench 5 mm, product code 9013.50.210 Official recall number · Z-2707-2016 Nonconforming Material/Component
device-recall:cfres:148882 iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data. Official recall number · Z-2686-2016 Software design
device-recall:cfres:148663 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear Official recall number · Z-2692-2016 Under Investigation by firm
device-recall:cfres:149195 Medical Linear Accelerator Official recall number · Z-2721-2016 Other
device-recall:cfres:148260 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis. Official recall number · Z-2713-2016 Under Investigation by firm
device-recall:cfres:147840 FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. Official recall number · Z-2690-2016 Software design
device-recall:cfres:149323 GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. Official recall number · Z-2731-2016 Software design
device-recall:cfres:144560 Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain. Official recall number · Z-1525-2016 Nonconforming Material/Component
device-recall:cfres:144589 TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis Official recall number · Z-1551-2016 Process control
device-recall:cfres:144969 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens. Official recall number · Z-1559-2016 Material/Component Contamination
device-recall:cfres:144692 Trinity Acetabular Shell Product Usage Total Hip Replacement. Official recall number · Z-1528-2016 Packaging process control
device-recall:cfres:144787 GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable. Official recall number · Z-1517-2016 Under Investigation by firm
device-recall:cfres:144583 TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis Official recall number · Z-1546-2016 Process control

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