Field Corrective Actions - Archive 2008
Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of patients, users or other persons. For example, advisory notices may contain the information from the manufacturer that he voluntarily recalls a medical device.
Please note that advisory notices are issued by the manufacturer, the authorized representative or the importer of medical devices. The respective company takes the responsibility for all information given in the advisory notice.
Search results 1 to 25 from a total of 673 (27 pages).
| Date posted | Reference-No. | Description | Product group |
|---|---|---|---|
| 2008.12.30 | 4497/08 |
Safety Notice for 5008 tubing systems, Fresenius Fresenius Medical Care informs per Field Safety Notice about the safe handling of the tubing systems for the hemodialysis systems 5008. The pre- or post-dilution port of the tubing system may break if the male Luer-Lock connector is connected too forceful and firm.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.29 | 4492/08 |
Corrective Action / Recall for Alkaline Phosphatase Calibrator (KC330), Siemens Corrective Action / Recall of Siemens Healthcare Diagnostics for Alkaline Phosphatase Calibrator (KC330) lot 7MD035 for the Dimension Vista System because of a degradation of enzyme activity which may result in an over-recovery of QC and patients’ results. The customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2008.12.29 | 4559/08 |
Recall / Corrective Action for UniCel Dxl Access Immunoassay Systems Wash Buffer II, Beckman Coulter Recall / Corrective Action of Beckman Coulter for UniCel Dxl Access Immunoassay Systems Wash Buffer II, Ref. A16793, Lot no. 70662 und 70637 because of sample pump operation errors when using these lot numbers. The customers were informed about the problem and requested to discard these lots, immediately.
|
In-vitro diagnostics |
| 2008.12.29 | 4455/08 |
Recall for M06K14-34 (gabControl Troponin I-Test), gabmed Recall of gabmed GmbH for gabControl Troponin I-Test (Lot: M06K14-34) because of false negative results for positive patient samples. The customers were requested to discontinue use, immediately, and to return the lot. Advisory Notice is only available in German language.
|
In-vitro diagnostics |
| 2008.12.29 | 4368/08 |
Corrective Action for ADVIA Centaur and ACS:180 Systems, Siemens Corrective Action of Siemens Healthcare Diagnostics for ADVIA Centaur and ACS:180 Systems: BNP 1,2,3 Quality Control Material Lot 383379 because of instability. The customers were informed about the problem and how to avoid it.
|
In-vitro diagnostics |
| 2008.12.23 | 4652/08 |
Recall for Dimension HM Reaction Vessels, Siemens Recall of Siemens Healthcare Diagnostics for Dimension HM Reaction Vessels (RXV1A) because of a physical defect (hole in the bottom portion of the vessel). The customers were informed about the problem and requested to discard the affected products.
|
In-vitro diagnostics |
| 2008.12.23 | 4483/08 |
Recall for Enzygnost Anti-Helicobacter pylori II/IgG, Siemens Recall of Siemens Healthcare Diagnostics for Enzygnost Anti-Helicobacter pylori II/IgG (OQOA), Lot No. 37243, 37385, 37434 and 37653, because of false positive results in the weak positive range. The customers were informed to discard the affected lots.
|
In-vitro diagnostics |
| 2008.12.23 | 4412/08 |
Recall for Microzid sensitive wipes, Schülke & Mayr GmbH Schülke & Mayr GmbH recalls all lots of Microzid sensitive wipes. The intended use of these wipes is the disinfection of medical devices and other surfaces. The disinfection efficacy is insufficient because of interaction between the material of the wipe and the disinfectant. Advisory Notice is only available in German language.
|
General equipment for medical treatment |
| 2008.12.22 | 4657/08 |
Recall for Philips urethral catheters, Coloplast Coloplast recalls certain lots of Philips urethral catheters from the market. If the metallic tip of the catheter detaches, this may lead to the patient having a foreign body in the lower urologic segments. Advisory Notice is only available in German language.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.22 | 4554/08 |
Recall for Ablation System Foot Switch, Boston Scientific Corp. The company Boston Scientific Corp. has issued a Field Safety Notice informing of a recall of select RF Ablation System Foot Switches used with the Maestro 3000 Controller and the EPT-1000XP Controller. If there is a short in the foot switch connector, an unintended delivery of RF energy can begin.
|
Medical electronics / Electromedical devices |
| 2008.12.17 | 4314/08 |
Recall of the der Resolve Biliary Drainage Catheters from Merit Medical Systems Recall of the der Resolve Biliary Drainage Catheters from Merit Medical Systems.The catheter tips may separate from the catheter shaft after placement, potentially resulting in patient injury (e.g. bowel perforation).
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.17 | 4477/08 |
Field Safety Notice to the COLLEAGUE Triple Channel Volumetric Infusion Pump, Baxter The company Baxter Healthcare Corp. notified of a change in the workflow on the COLLEAGUE Triple Channel Volumetric Infusion Pump with software version 5.08.92 in comparison to previous software versions. For example, the primary infusion must be stopped when in Dose Mode, in order to programm a piggyback infusion.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.17 | 4598/08 |
Recall of one lot of the central venous catheter Premicath Vygon GmbH & Co. KG recalls one lot of the central venous catheter Premicath from the market. Introduction of the catheter may lead to vessel injury because the tip of the mandrin may protrude from the catheter tip.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.12 | 4329/08 |
Field Safety Notice of multiplane Transesophageal Transducer Toshiba is issuing a Field Safety Notice about the proper use of multiplane Transesophageal Transducer, model PET-511BTM. The transducer may buckle (bend back on itself) if inserted incorrectly.
|
Ultrasonics |
| 2008.12.12 | 4427/08 |
Field Safety Notice for Flocare Infinity Enteral Feeding Pump from Nutricia Medical Device B.V. The company Nutricia Medical Device B.V. has issued a Field Safety Notice concerning an accelerated maintenance program incl. pump check and software-upgrade for Flocare Infinity Enteral Feeding Pump.The manufacturer discovered a software irregularity that can lead the pump delivering feed at a higher flow rate than the rate programmed.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.11 | 3615/08 |
Field Safety Notice of application syngo Workflow MLR from Siemens Healthcare Siemens Healthcare has issued a Field Safety Notice about a potential malfunction and hence a potential hazard to patient when using the application syngo Workflow MLR with version VB 30A_SP1, VB 30A_SRV1.
|
Radiological technology |
| 2008.12.11 | 4141/08 |
Field Safety Notice of arterial filter Quart from Maquet Cardiopulmonary AG The manufacturer Maquet Cardiopulmonary AG informs via Field Safety Notice that the arterial filter Quart possibily can not be de-aerated due to a production problem. The user should take care oft this matter during set up / priming.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.11 | 4571/08 |
Recall of Promos Releasing Clamp and Promos Glenosphere Loosening Adapter from Smith & Nephew Orthopaedics AG Smith & Nephew Orthopaedics AG recalls several lot numbers of Promos Releasing Clamp (Model 420189) and Promos Glenosphere Loosening Adapter (Model 24000047) due to a breakage of the Releasing Clamp.
|
Medical instruments |
| 2008.12.11 | 4575/08 |
Recall of Variall Connecting Rod from Zimmer GmbH The manufacturer Zimmer GmbH recalls the Variall Connecting Rod M16, Model 01.00049.073, Lot 07268556. Some instruments may fracture at the welding during use in surgery.
|
Medical instruments |
| 2008.12.11 | 4457/08 |
Field Safety Notice of battery caps in insulin pumps Med Trust Handelsgesellschaft mbH exchanges battery caps in insulin pumps manifactured by Animas Corporation.
|
Injection/ Infusion/ Transfusion/Dialysis |
| 2008.12.09 | 4126/08 |
Information to S-ROM-hipshaft from DePuy DePuy informs that the 12/14 S-ROM-hipshaft should not be combined with certain DePuy modular heads. The Advisory Notice is only available in German language.
|
Non-active implants |
| 2008.12.09 | 3102/08 |
Recall of Genesis II knee system from Smith & Nephew Orthopaedics GmbH Smith & Nephew Orthopaedics GmbH are recalling 1 lot of CR Tibiabasis of their Genesis II knee system due to mislabeling. Advisory notice is only available in German language.
|
Non-active implants |
| 2008.12.09 | 2897/08 |
Field Safety Notice for training device Diagnos med Schnell Trainingsgeräte GmbH has issued a Field Safety Notice concerning additional contraindications for training device Diagnos med. The device is marketed in Austria and Germany. The Advisory Notice is only available in German language.
|
Physical therapy |
| 2008.12.08 | 4524/08 |
Field Safety Notice for Path Finder and InCompass T-Handle Driver from Abbott Spine Inc. The manufacturer Abbott Spine Inc. initiated a field safety corrective action regarding Path Finder and InCompass T-Handle Driver (Models 2151-4, 2151-5, 2151-6). An analysis had determined that the instruments were not being assembled properly after cleaning due to insuffifient cleaning instructions.
|
Medical instruments |
| 2008.12.08 | 4541/08 |
Recall of the Sihouette Axial Torque Wrench from Zimmer Spine USA The manufacturer Zimmer Spine, USA initiated a recall of the Sihouette Axial Torque Wrench (model number 7010-0151-01, lots: P050120, P041466). Retourned wrenches had shown that the torque wrench may apply torque below the intended range.
|
Medical instruments |
