Recall Archives December 2. June 2. 01. 2Recalls as of June. Recalls as of June. Recalls as of May. Recalls as of May. Recalls as of May 9.
Read alerts_20110105_eng_08-10.pdf text version. Major Safety Alerts in December 2010 *Note: FDA = Food and Drug Administration, United States of America; MHRA. Clearly On Target The Protura™ Robotic Patient Positioning System is the ultimate in robotic patient motion management. Designed to integrate with most IGRT. Important Safety Alerts,Recalls and alerts. [] Medical Device Safety Alert: Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and. Jan 20 Mar 20 May 2008 June 2008 July 20 Sep 20 Nov 20 Jan 20 Mar 20 May 20.
Quality assurance for image-guided radiation therapy utilizing CT-based technologies: A report of the AAPM TG-179 Jean-Pierre Bissonnettea) Task Group 179, Department. Readbag users suggest that alerts_20110614_eng.pdf is worth reading. The file contains 32 page(s) and is free to view, download or print. Mdi Consultants inc., are FDA, CE mark, ISO 9000, MDD, IVDD, HACCP, gmp compliance consultants and also consult for md marketing, medical devices, gmp, clinical.
Recalls as of May 2. Recalls as of. April 2. Recalls as of. April 1. Recalls as of. April 1.
Elekta XVI Volumetric Imaging and Registration QA With the MIMI Phantom Kurt Stump, Ph.D., DABR Santa Maria Radiation Oncology Medical Center. Development of image quality assurance measures of the ExacTrac localization system using commercially available image evaluation software and hardware for image.
Recalls as of. April 4, 2. Recalls as of. March 2. Recalls as of. March 2. Recalls as of March. Recalls as of March.
Recalls as of. February 2. Recalls as of. February 2. Recalls as of. February 1. Recalls as of. February 0. Recalls as of. January 2. Recalls as of. January 1. Recalls as of. January 1.
Recalls as of. Januray 0. Attention all mdi Clients: The following is condensed. FDA Enforcement Report.
June. 1. 3, 2. 01. CLASS IIPRODUCT: Heparin Lock Flush.
Solution 1. 00 Unit/m. L, USP 3 ml, 5m. L, 6 ml fill in a 1. L Flush Syringe, NDC. Used to maintain patency of vascular access devices designed for. Export product for sale in Colombia are used for.
Recall # Z- 1. 70. MANUFACTURER. Excelsior Medical Corp., Neptune, NJ, by letter dated May 4. Firm initiated recall is ongoing. REASON. Some lots. Heparin Lock Flush, USP Syringes (3 m.
L fill in 1. 0 m. L syringe, 4 m. L fill in 1. L syringe, 5 m. L fill in 1.
L syringe), failed Anti- Factor IIa assay for. PRODUCT: Sterrad Cyclesure 2.
Biological Indicator, P/N: 1. The STERRAD CYCLESURE 2. Biological Indicator. STERRAD Sterilization System cycles.
Recall # Z- 1. 77. MANUFACTURER. Advanced Sterilization Products, Irvine, CA, by letter dated. March 1. 6, 2. 01. Firm initiated recall is ongoing. REASON. Certain LT1, Tantalum ASTM F5. Non- Sterile- Single Use Only (See package. CAUTION: Federal (United.
States) law restricts these devices to sale by or on the order of a. Manufactured and distributed by: CAPTIVA. SPINE***captivaspine. Alternate A1. A #1 Jupiter, FL 3. Tel. 8. 77- 7. 72- 5. Fax: 8. 66- 3. 18- 3.
Email: info@captivaspine. FPL - F is. Fuse. LOX, P is Plif, C is Lorditic Products subject to recall: Fuse. LOX Lumbar. Lorditic: Lorditic - 7mm x 2. Part Number: FPL2.
Lot Number 0. 71. Lorditic - 8mm x 2.
Part Number FPL2. Lot Number 0. 71. Lorditic - 9mm x. Part Number: FPL2. Lot Number 0. 71.
Lorditic - 1. 0mm x 2. Part. Number: FPL2. Lot Number 0. 71. Lorditic - 1. 1mm x 2. Part Number: FPL2.
Lot Number 0. 71. Lorditic - 1. 2mm x 2. Part Number: FPL2.
Lot Number. 0. 71. Lorditic - 1. 3mm x 2. Part Number FPL2. Lot Number 0. 71. Products are packaged individually and shipped as replacement parts to be placed.
Fuse. LOX Lumbar Caddy which is placed in the Fuse. Lox Lumbar Sterilization. The sterilization tray is distributed on consignment. The Fuse. LOX Lumbar. Cage implant is an intervertebral body fusion device indicated for. L2 to S1 in patients with degenerative disc disease (DDD) with up to.
Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain. These patients should be skeletally mature and have. The Fuse. LOX Lumbar Cage Implant is. Recall #. Z- 1. 78. Accessories for the Captiva Spine Fuse. LOX Lumbar Cage. The Trial.
Captiva Spine Fuse. LOX Lumbar product. It. is not generally sold as an individually packaged product. Trial products are. Fuse. LOX Lumbar Caddy which is placed in the. Fuse. Lox Lumbar Sterilization tray.
The sterilization tray is distributed on. FPT - F is Fuse. LOX, P is Plif, and T is Trial. Products subject to. Fuse. LOX Lumbar Trials Trial - 7mm x 2.
Part Number: FPT2. Lot Number. 8. 11. Trial - 8mm x 2. 5mm Part Number FPT2. Lot Number 8. 11. Trial - 9mm. x 2.
Part Number: FPT2. Lot Number 8. 11. Trial - 1. 0mm x 2. Part Number. FPT2.
Lot Number 8. 11. Trial - 1. 1mm x 2. Part Number: FPT2. Lot Number. 8. 11. Trial - 1. 2mm x 2.
Part Number: FPT2. Lot Number 8. 11. Trial - . 1. 3mm x 2. Part Number FPT2. Lot Number 8. 11. Trial - 1. 4mm x 2.
Part. Number FPT2. Lot Number 8. 11. The Fuse. LOX Lumbar Cage implant is an. L2 to S1 in patients.
DDD) with up to Grade 1 spondylolisthesis at the. DDD is defined as back pain of discogenic origin with. These patients should be skeletally mature and have had six months of. The Fuse. LOX Lumbar Cage Implant is designed for use.
Recall # Z- 1. 78. Accessories for the Captiva Spine Fuse. LOX Lumbar Cage. The Fuse. LOX Lumbar. Inserter product is a reuseable component of the Captiva Spine Fuse.
LOX Lumbar. product. It is not generally sold as an individually packaged product. Inserter. products are shipped as a component of the Fuse. LOX Lumbar Caddy which is placed.
Fuse. Lox Lumbar Sterilization tray. The sterilization tray is distributed. FPT - F is Fuse. LOX, P is Plif, and I is Inserter. Products. subject to recall: Fuse. LOX Lumbar Inserter Inserter - Part Number: FPT0. Lot. Number 6. 11. Quantity distributed (8) is found in table on page 5 of 6.
The. Fuse. LOX Lumbar Cage implant is an intervertebral body fusion device indicated. L2 to S1 in patients with degenerative disc disease (DDD) with. Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back. These patients should be skeletally mature and. The Fuse. LOX Lumbar Cage Implant.
Recall #. Z- 1. 78. MANUFACTURER. Captiva Spine, Inc., Jupiter, FL, by letter dated May 4, 2. Firm initiated recall is ongoing.
REASON. FDA advised the firm that there is inadequate support for. Pivotec Lumbar Interbody Fusion. Device. PRODUCT: The Brilliance i.
CT and i. CT SP are Computed Tomography X- Ray Systems intended. These devices may. The Brilliance i. CT and i. CT SP are used to produce. Brilliance i. CT: Model#. Brilliance i. CT SP: Model# 7.
Recall # Z- 1. 79. MANUFACTURER. Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by.
May 8, 2. 01. 2. Firm initiated recall is ongoing. REASON. Philips. is issuing a software update (version 3.
Brilliance i. CT and i. CT SP. systems currently running software version 3. A review was conducted of all nonconformances that. None of these nonconformances result in.
The nonconformance documented below had the highest score. Calibration ring. PRODUCT. Lipofilter 3.
ASP- CAN- 2, labeled in part ***Product Usage: A fat. Recall #. Z- 1. 79. MANUFACTURER. Micro. Aire Surgical Instruments, LLC, Charlottesville, VA, by. April 2. 6, 2. 01. Firm initiated recall is ongoing. REASON. Medical device was not manufactured under Good Manufacturing.
Procedures and a user may be unable to sterilize the device according to. PRODUCT: Columbus Tibia Plateau. Columbus REVISION Knee System) Product Usage - The Columbus. Revision Knee System is indicated for use in reconstruction of the diseased knee.
Recall # Z- 1. 79. MANUFACTURER. Recalling. Firm: Aesculap Implant Systems, Center Valley, PA, by telephone and letter dated. February 2. 1, 2. Manufacturer: Aesculap.
AG, Tuttlingen, Germany. Firm initiated recallis ongoing. REASON. During an internal quality inspection, the tibia plateau was.
There is a potential for misalignment between. PRODUCT. Plasma. Jet. Open Surgery Handpiece (Part of the Plasma.
Jet Neutral Plasma Surgery System) The. Plasma. Jet system is a neutral plasma surgery system that is designed for cutting. Recall # Z- 1. 79. MANUFACTURER. Plasma Surgical Inc., Roswell, GA, by letter dated April 2. Firm initiated recall is ongoing. REASON. Potential. The following is condensed.
FDA Enforcement Report. June 6, 2. 01. 2. CLASS IPRODUCT: Abacus TPN Calculating. Software Product Usage: LIMS Windows- based program for order entry and TPN.
Catalogue Numbers: 8. Abacus Calculator Only (Abacus CE). Abacus Single Work Station (Abacus SE) 8.
Abacus Multi- Work. Station (Abacus ME). Recall # Z- 1. 43. MANUFACTURER. Baxa Corp., Englewood, CO, by letter dated January 1. Firm initiated recall is ongoing.
REASON. Ordering salt- based ingredients on an ion- based template. PRODUCT: 1) Other- Sonic Generic. Ultrasound Transmission Gel 2.
L Hypoallergenic Product Usage is a non- sterile. Recall # Z- 1. 65. Other- Sonic. Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a. Recall # Z- 1. 65. MANUFACTURER. Pharmaceutical Innovations, Inc., Newark, NJ, by letter dated March 0. March 9, 2. 01. 2 and an Inventory Withdrawal letter. March 2. 3, 2. 01.
Firm initiated recall is ongoing. REASON. Recall due to possible microbial contamination. PRODUCT: 1) Non- DEHP Microbore Administration Set with Non- Vented Spike Packaged. Assembly, product code: 3. Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration. Tubing Sets and user accessories, provide a means for the volumetric delivery of.
Parenteral, Enteral, Epidural, Subcutaneous and Intravenous. Recall # Z- 1. 65. Non- DEHP Microbore Administrative Set with. Female Luer Adapter Packaged Assembly, product code: 3.
Method of. Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System. PVC Administration Tubing Sets and user accessories, provide a.
Parenteral, Enteral. Epidural, Subcutaneous and Intravenous applications. Recall # Z- 1. 66. Epidural Admin Set with Non- Vented Bag Spike and 0.
Micron Filter Package. Assembly, product code: 3. Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration. Tubing Sets and user accessories, provide a means for the volumetric delivery of. Parenteral, Enteral, Epidural, Subcutaneous and Intravenous. Recall # Z- 1. 66.
Non- DEHP Admin Set with Non- Vented Spike. Micron Filter Packaged Assembly, product code: 3. Method of. Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System. PVC Administration Tubing Sets and user accessories, provide a. Parenteral, Enteral. Epidural, Subcutaneous and Intravenous applications.
Recall # Z- 1. 66. Non- DEHP Admin Set with Non- Vented Spike and 1. Micron Filter Packaged. Assembly, product code: 3. V, Method of Sterilization using Ethylene. Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC. Administration Tubing Sets and user accessories, provide a means for the.
Parenteral, Enteral, Epidural. Subcutaneous and Intravenous applications. Recall # Z- 1. 66. Non- DEHP. Admin Set with Non- Vented Spike and 0.
Micron Filter Packaged Assembly, product. Method of Sterilization using Ethylene Oxide. The Curlin. Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets.