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FDA Recalls and/or Manufacturer Product Advisories and Field Corrections
Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.
ABBOTT DIABETES CARE, INC., Alameda, California. Test Strips: 1) Precision Xceed Pro; 2) Optium EZ; 3) MediSense Strips and Electrodes; 4) Optium; 5) Precision Point of Care; 6) Precision Xtra strips, Monitoring System, and Precision G3b Smartblue; 7) ReliOn Ultima. Class I. Firm initiated recall ongoing. Firm notified users by letter on December 22, 2010. Volume in Commerce: 359 total lots, 1,000,000 strips per lot. Reason: Certain lots may generate erroneously low blood glucose results. FDA recalls #Z-0994/1000-2011. FDA Enforcement Report, 02/16/11.
ADVANCED STERILZATION PRODUCTS, Irvine, California: Manufacturer: Amcor Flexibles Healthcare, Inc., Mundelein, Illinois. Self-Seal Pouch with STERRAD Chemical Indicator 12332: Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter beginning June 23, 2010. Volume in Commerce: 470 units. Reason: The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves. FDA recall #Z-1393-2011. FDA Enforcement Report, 03/02/11.
AMS INNOVATIVE CENTER, San Jose, California. Laser: AMS GreenLight PV Laser System; fiber accessories. Class II. Firm initiated recall ongoing. Firm notified users by express mail on February 8, 2010 and September 15, 2010. Volume in Commerce: 242,000 units. Reason: A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn. FDA recall #Z-1229-2011. FDA Enforcement Report, 02/23/11.
BAXTER HEALTHCARE CORPORATION, Round Lake, Illinois: Manufacturer: Baxter Healthcare Corporation, Singapore. Syringe Infusion Pump: InfusOR. Class II. Firm initiated recall ongoing. Firm notified users by letters dated January 11, 2011. Volume in Commerce: 39,725 units. Reason: Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures .53 inches ð.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum of .51 inches for the negativeterminal diameter. FDA recall #Z-1378-2011. FDA Enforcement Report, 03/02/11.
CONMED ELECTROSURGERY, Centennial, Colorado. Electrosurgical Generator: 1) 2450 Generator, REF 60-2450-100, 100V; 2) 2450 Generator, REF 60-2450-120, 120V; 3) 2450 generator, REF 60-24250-220, 220V; 4) 2450 Generator, REF 60-2450-230, 230-240V; 5) 2450 Generator, REF 60-2450-120-69, 120V. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 27, 2010. Volume in Commerce: 2,323 units. Reason: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. FDA recalls #Z-1362/1366-2011. FDA Enforcement Report, 02/23/11.
FUJINON INC., Wayne, New Jersey. Fujinon Endoscope Series: Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 7, 2011. Volume in Commerce: 783 units. Reason: The FICE feature installed in video endoscopic processors is being disabled since this feature should have been reviewed under premarket notification/510K process. FDA recall #Z-1067-2011. FDA Enforcement Report, 02/16/11.
GE HEALTHCARE, IT, Barrington, Illinois: Manufacturer: Triple G Systems Group, Inc., Markham, Ontario, Canada. Software: GE Centricity Laboratory software. Class II. Firm initiated recall ongoing. Firm notified users by letters dated December 12, 2010. Volume in Commerce: 26 units. Reason: The GE Centricity Laboratory System Software has safety issues with the “Telephone List” function, the “Anatomic Pathology” application, and the Instrument Interface IO module that may impact patient safety. FDA recall #Z-1245-2011. FDA Enforcement Report, 02/23/11.
GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical System Israel LTD, Tirat Hacarmerl, Israel. Workstation: Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 12, 2011. Volume in Commerce: 6,046 units. Reason: GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Workstation. 2. Inaccurate PET SUV values may be calculated when data is retrieved from PACS after being processed in the Xeleris. 3. Wrong marking of Early and Late result series on display in Brain SPECT when 2 result series are opened in compare mode. These issues may impact patient safety. FDA recall #Z-1250-2011. FDA Enforcement Report, 02/23/11.
HILL-ROM, INC., Batesville, Indiana. Comfort Sling: Liko Comfort Sling Plus Model 330. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 9, 2011. Volume in Commerce: 10 units. Reason: Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient at risk of falling out. FDA recall #Z-1396-2011. FDA Enforcement Report, 03/02/11.
HILL-ROM, INC., Batesville, Indiana. Patient Beds: 1) Hill-Rom TotalCare Bed, P1900; 2) Hill-Rom TotalCare Bariatric Bed, P1840. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 19, 2011. Volume in Commerce: 945 units. Reason: The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. FDA recalls #Z-1220/1221-2011. FDA Enforcement Report, 02/16/11.
HILL-ROM MANUFACTURING INC., Charleston, South Carolina. Patient Beds: 1) Flexicair II Model number 13000; 2) Flexicair MC 3, Model number M4000. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 15, 2010. Volume in Commerce: 43 units. Reason: Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. FDA recalls #Z-1253/1254-2011. FDA Enforcement Report, 02/23/11.
MEDELA INC., McHenry, Illinois. Breast Pump: Pump In Style Advanced (PNSA) Pump. Manufacture dates: 2/10/10 through 3/3/10. Class III. Firm initiated recall ongoing. Firm notified users by letter date January 11, 2011. Volume in Commerce: 11,154 units. Reason: The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or make a clicking sound. FDA recall #Z-1224-2011. FDA Enforcement Report, 02/16/11.
TOSHIBA AMERICA MEDICAL SYSTEMS, INC., Tustin, California: Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. CT Whole Body Scanner: Toshiba TSX-301A AQUILION. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 7, 2010. Volume in Commerce: 44 units. Reason: Incorrect Dose Calculation. FDA recall #Z-1257-2011. FDA Enforcement Report, 02/23/11.
[UPDATED 02/11/2011] Triad Alcohol Prep Pads are packaged with devices manufactured by Neuro Resource Group. The Triad alcohol prep pads should not be used. [UPDATED 02/01/2011] FDA reminded healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.
ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
RECOMMENDATION: If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.