| device-recall:cfres:113982 |
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Official recall number · Z-0306-2013 |
Software design |
| device-recall:cfres:111544 |
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. |
Official recall number · Z-0282-2013 |
Device Design |
| device-recall:cfres:114273 |
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques |
Official recall number · Z-0337-2013 |
Process control |
| device-recall:cfres:111543 |
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. |
Official recall number · Z-0281-2013 |
Device Design |
| device-recall:cfres:113679 |
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. |
Official recall number · Z-0207-2013 |
Reprocessing Controls |
| device-recall:cfres:113264 |
Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx |
Official recall number · Z-0230-2013 |
Error in labeling |
| device-recall:cfres:112645 |
Alloclassic SL Shaft |
Official recall number · Z-0210-2013 |
Error in labeling |
| device-recall:cfres:113259 |
Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem |
Official recall number · Z-0227-2013 |
Error in labeling |
| device-recall:cfres:85292 |
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. |
Official recall number · Z-0267-2013 |
Nonconforming Material/Component |
| device-recall:cfres:114348 |
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. |
Official recall number · Z-0269-2013 |
Error in labeling |
| device-recall:cfres:110039 |
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. |
Official recall number · Z-0263-2013 |
Nonconforming Material/Component |
| device-recall:cfres:128642 |
Latex Dental Dams labeled as Non-Latex Dental Dams |
Official recall number · Z-2151-2014 |
Packaging change control |
| device-recall:cfres:128310 |
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures. |
Official recall number · Z-2118-2014 |
Nonconforming Material/Component |
| device-recall:cfres:129166 |
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal. |
Official recall number · Z-2160-2014 |
Nonconforming Material/Component |
| device-recall:cfres:128489 |
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. |
Official recall number · Z-2166-2014 |
Software design |
| device-recall:cfres:128288 |
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler. |
Official recall number · Z-2135-2014 |
Device Design |
| device-recall:cfres:127104 |
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization. |
Official recall number · Z-2170-2014 |
Under Investigation by firm |
| device-recall:cfres:128768 |
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit. |
Official recall number · Z-2181-2014 |
No Marketing Application |
| device-recall:cfres:128228 |
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue |
Official recall number · Z-2047-2014 |
Package design/selection |
| device-recall:cfres:128258 |
ACL TOP 500 CTS, automated coagulation laboratory instrument. |
Official recall number · Z-2064-2014 |
Device Design |
| device-recall:cfres:128237 |
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. |
Official recall number · Z-2053-2014 |
Process control |
| device-recall:cfres:128225 |
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. |
Official recall number · Z-1957-2014 |
Nonconforming Material/Component |
| device-recall:cfres:128389 |
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. |
Official recall number · Z-1945-2014 |
Packaging change control |
| device-recall:cfres:128140 |
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic |
Official recall number · Z-1990-2014 |
Component design/selection |
| device-recall:cfres:128106 |
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag. |
Official recall number · Z-1963-2014 |
Software design |
