Recall of ANIMAS 2020 INSULIN INFUSION PUMP (WARRANTY REPLACEMENT VARIOUS COLOURS)

Recall

48471

II

2012-10-19

Canada

HC

the animas 2020 insulin infusion pumps will cease to operate on january 1 2016 and will result in a call service alarm that will be displayed on the pump display and insulin delivery by the pump will be halted. 80468 2012-10-04 00:00:00 iii zoo pack elastics ormco z-pak elastics model catalog: 630-0040 (lot serial: 061277866) ormco corporation glendora us a recall is being conducted as a result of mispackaging. boxes of kangaroo elastics may contain individual packages of kangaroo and impala elastics. 80490 2012-12-10 00:00:00 iii abbott m2000 system - m2000sp instrument abbott m2000 system - m2000sp instrument model catalog: 9k14-02 (lot serial: all lots); model catalog: 9k14-01 (lot serial: all lots) abbott laboratories limited. diagnostic division mississauga ca an issue with the m2000sp instrument software has been identified whereby after a series of steps if changes are made to the control or calibrator information on the sample extraction assay details screen the changes are not saved. 80492 2012-12-11 00:00:00 ii forma branded stericult forma branded stericult model catalog: 3310 (lot serial: na); model catalog: 3307 (lot serial: na); model catalog: 370 (lot serial: na); model catalog: 380 (lot serial: na) fisher scientific nepean ca incubator's outer door may fall while opened. cause may be related to variation in production process of the coated metal hinges by the supplier. 80493 2012-12-03 00:00:00 ii dualhemo mcable infinity mcable - dual hemo model catalog: ms20783 (lot serial: >10 numbers contact mfg) draeger medical canada inc. mississauga ca in some cases the displayed value for the invasive blood pressure measurement of the iacs may be lower than the actual patient values. 80494 2012-12-13 00:00:00 iii dimension vista system-urinary/cerebrospinal fluid protein assay dimension vista system - urinary/cerebrospinal fluid protein assay model catalog: k3026 (lot serial: 11349bb) siemens healthcare limited oakville ca there is an increase in the rate of absorabance errors with the dimension vista urinary/cerebrospinal fluid protein (ucfp) flex reagent cartridge during calibration. patient results are not impacted but may be delayed. 80495 2013-02-13 00:00:00 ii apex woundpro apex negative wound therapy system model catalog: 84635400181 (lot serial: > 10 numbers contact mfg); model catalog: 84635400181 (lot serial: e000627aac); model catalog: 84635400181 (lot serial: e001490aac); model catalog: 84635400181 (lot serial: e000725aac); model catalog: 84635400181 (lot serial: e000722aac); model catalog: 84635400181 (lot serial: e000642aac); model catalog: 84635400181 (lot serial: e001668aac); model catalog: 84635400181 (lot serial: e001663aac); model catalog: 84635400181 (lot serial: e001486aac); model catalog: 84635400181 (lot serial: e000724aac); model catalog: 84635400181 (lot serial: e000646aac); model catalog: 84635400181 (lot serial: e000638aac); model catalog: 84635400181 (lot serial: e001665aac); model catalog: 84635400181 (lot serial: e001662aac); model catalog: 84635400181 (lot serial: e000726aac); model catalog: 84635400181 (lot serial: e000723aac); model catalog: 84635400181 (lot serial: e000644aac); model catalog: 84635400181 (lot serial: e001664aac) therapeutic surface solutions hamilton ca accuro has received reports of some apex pumps either failing to operate or malfunctioning at times without notifying the user of such failure or malfunction on the unit's display screen. 80496 2012-12-14 00:00:00 ii unicel dxi 800 access immunoassay system - analyzer - class ii unicel dxi 800 access immunoassay system - analyzer - class ii model catalog: 973100 (lot serial: > 10 numbers contact mfg.); model catalog: a30260 (lot serial: 900330); model catalog: a30260 (lot serial: 900363); model catalog: a30260 (lot serial: 900228); model catalog: a30260 (lot serial: 900227); model catalog: a30260 (lot serial: 900241); model catalog: a30260 (lot serial: 900334); model catalog: a71461 (lot serial: 900359); model catalog: a64935 (lot serial: 900359); model catalog: 4773 (lot serial: 900359); model catalog: a30260 (lot serial: 900304); model catalog: a30260 (lot serial: 900403); model catalog: a64871 (lot serial: 900330); model catalog: 4771 (lot serial: 900330); model catalog: a64871 (lot serial: 900228); model catalog: 4771 (lot serial: 900228); model catalog: a64871 (lot serial: 900227); model catalog: 4771 (lot serial: 900227); model catalog: 973100 (lot serial: > 10 numbers contact mfg); model catalog: a59102 (lot serial: 600785); model catalog: 4768 (lot serial: 600785); model catalog: a59102 (lot serial: 601705); model catalog: 4768 (lot ser beckman coulter canada l.P. mississauga ca as a part of the 10000-test maintenance procedure which occurs on average once a month in the dxi family of instruments customers are required to replace aspirate and dispense probes and tubing. the dispense and aspirate tubing can become pinched or damaged as a result of incorrect customer installation of the tubing after probe maintenance or replacement which may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results. 80497 2012-12-17 00:00:00 ii mobilediagnost wdr mobilediagnost wdr model catalog: 9890 010 8952x (lot serial: n/a) philips electronics ltd. markham ca 1. when the operator moves an image to another view the electronic marker might be placed at the wrong anatomical position in the resulting image. 2. if by an electrical connection failure between motor speed sensor and digital motion control board or a related software defect the movement speed regulation does not work as intended the device may move with increasing speed and/or into a wrong direction after releasing the dead man switch (handle bar) during 1.5 seconds maximum until the brake is activated. 80498 2012-12-17 00:00:00 ii vitros 5600 integrated system vitros 5600 integrated system model catalog: 6802413 (lot serial: > 10 contact manufacturer.); model catalog: 1922814 (lot serial: > 10 contact manufacturer.); model catalog: 680 2783 (lot serial: > 10 contact manufacturer.) ortho-clinical diagnostics markham ca this recall pertains to an accessory used on the vitros 5600 3600 and eci systems. ocd has determined that some vitros vapor adsorption cartridge cartons (code 6800100) incorrectly contain a particulate cartridge (part j19612). in some instances the particulate cartridge has been inadvertently installed on the vitros system instead of the intended vitros vapor adsorption cartridge and customers observed biased results. 80522 2012-12-17 00:00:00 iii nova statsensor statsensor-creatine hospital meter kit model catalog: 44052 (lot serial: all lot codes); model catalog: 46766 (lot serial: all lot codes); model catalog: 47116 (lot serial: all lot codes) nova biomedical corporation waltham us end users were notified that the rechargeable lithium battery has a finite use life and as of august 2012 is labelled with an expiration date on the battery label. 80571 2012-12-20 00:00:00 i plum a+3 infusion pump plum a+3 infusion pumps model catalog: 12618 (lot serial: all serial numbers); model catalog: 20678 (lot serial: all serial numbers); model catalog: 20792 (lot serial: all serial numbers); model catalog: 20679 (lot serial: all serial numbers); model catalog: 12391 (lot serial: all serial numbers) hospira healthcare corporation saint-laurent ca the door roller assembly on the plum a+/a+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or overdelivery during the removal of the iv administration set's cassette from the pump. 80573 2012-12-04 00:00:00 iii bipolar endostasis (best) probe best probe bipolar endostasis probe model catalog: 91007 (lot serial: n/a) meditron devices llc waldwick us unlicensed class 2 medical devices sold into canada. 80604 2012-12-13 00:00:00 iii antimicrobial susceptibility discs antimicrobial susceptibility discs model catalog: ct0036b (lot serial: 1191122); model catalog: ct0036b (lot serial: 1198342); model catalog: ct0036b (lot serial: 1194944) oxoid company nepean ca cartridges may present atypical results and the continued use of this lot could result in a false indication of sensibility to nitrofurantoin 80606 2012-12-17 00:00:00 ii trigen titanium nail system - intertan short nails trigen titanium nail system - intertan short nails model catalog: 71675210 (lot serial: 12ft19274); model catalog: 71675204 (lot serial: 12ft19274); model catalog: 71675204 (lot serial: 12et19095); model catalog: 71675210 (lot serial: 12et19095) smith & nephew inc. mississauga ca the 125 degree nail (product code 71675204) was laser marked as 130 degrees" while the 130 degree nail (product code 71675210) was laser marked as "125 degrees". an incorrect neck angle was marked on the 2 products.