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U.S. Department of Health and Human Services

Class 2 Device Recall Disetronic DTron

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 Class 2 Device Recall Disetronic DTronsee related information
Date Initiated by FirmJuly 15, 2005
Date PostedAugust 06, 2005
Recall Status1 Terminated 3 on February 07, 2006
Recall NumberZ-1105-05
Recall Event ID 32659
510(K)NumberK043000 
Product Classification Pump, Infusion, Insulin - Product Code LZG
ProductDisetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Code Information All units with the following lot numbers being used by patients 13 years of age or younger: lots 4013674 through 4022628. The last affected lot expires in April 2007.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactPump Support
800-688-4578
Manufacturer Reason
for Recall		The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
FDA Determined
Cause 2		Other
ActionThe firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.
Quantity in Commerce107 pediatric patients use the device.
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZG
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