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U.S. Department of Health and Human Services

Class 2 Device Recall Power adapter for the HemoPoint H2 meter, Model G3000 series

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  Class 2 Device Recall Power adapter for the HemoPoint H2 meter, Model G3000 series see related information
Date Initiated by Firm February 08, 2018
Create Date August 24, 2018
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-2926-2018
Recall Event ID 80562
510(K)Number K081719  
Product Classification System, hemoglobin, automated - Product Code GKR
Product Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
Code Information Serial number range of affected power adapters: 41800001-41804000
Recalling Firm/
Manufacturer		 Stanbio Laboratory, LP
1261 N Main St
Boerne TX 78006-3014
For Additional Information Contact Technical Support
800-531-5535
Manufacturer Reason
for Recall		 The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.
Quantity in Commerce 2,804 devices
Distribution Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GKR and Original Applicant = STANBIO LABORATORY
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