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The Diabetes : News : Recalls Category
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Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
[ Hits: 1 | Rating: 0.00 | Votes: 0 ]
[ Added: 17-Apr-2006 | Modified: 17-Apr-2006 ]

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Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius. This present a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organism into previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Boca Medical continues to evaluate possible risks.

Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product
[ Hits: 1 | Rating: 0.00 | Votes: 0 ]
[ Added: 23-May-2006 | Modified: 23-May-2006 ]

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Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 41 boxes of Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and 2320 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5KEO1 as displayed on the inner case. The products are being recalled because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Previous recalled lot was 5GEX1.

Class I Medical Device Recall - Bayer Ascensia® Contour® Blood Glucose Monitoring System
[ Hits: 7 | Rating: 0.00 | Votes: 0 ]
[ Added: 13-Jul-2007 | Modified: 13-Jul-2007 ]

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The meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL.

Disetronic Medical Systems, Inc. Announces a Voluntary Recall of the D-TRON Adapters, Used With the D-TRONplus Insulin Pump
[ Hits: 3 | Rating: 0.00 | Votes: 0 ]
[ Added: 1-Aug-2005 | Modified: 1-Aug-2005 ]

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FOR IMMEDIATE RELEASE -- Indianapolis, IN -- July 29, 2005 -- Disetronic Medical Systems, Inc., Fishers, Indiana is announcing a voluntary nationwide recall of its D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. of insulin.

Medtronic Recalls Quick-Set® Plus Infusion Sets
[ Hits: 10 | Rating: 0.00 | Votes: 0 ]
[ Added: 20-May-2004 | Modified: 20-May-2004 ]

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NORTHRIDGE, Calif., May 18, 2004 (FDA MedWatch)-- Medtronic, Inc. today announced that its Diabetes division began notifying diabetic patients, healthcare professionals and distributors that it is conducting a nationwide recall of Quick-set ® Plus infusion sets because of problems that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations.

Test Strip Recall for CONTOUR TS
[ Hits: 6 | Rating: 0.00 | Votes: 0 ]
[ Added: 26-Dec-2007 | Modified: 26-Dec-2007 ]

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FOR IMMEDIATE RELEASE -- U.S. -- December 21, 2007 --- Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter.

Voluntary Nationwide Recall of all ACCU-CHEK™ Ultraflex Infusion Sets
[ Hits: 2 | Rating: 0.00 | Votes: 0 ]
[ Added: 4-Apr-2006 | Modified: 4-Apr-2006 ]

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FOR IMMEDIATE RELEASE -- Fishers, IN -- April 3, 2006 -- Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind. announced today a voluntary nationwide recall of all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

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