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U.S. Department of Health and Human Services

Class 2 Device Recall Blue Belt Technologies

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  Class 2 Device Recall Blue Belt Technologies see related information
Date Initiated by Firm July 19, 2013
Date Posted August 21, 2013
Recall Status1 Terminated 3 on November 14, 2013
Recall Number Z-1995-2013
Recall Event ID 65834
510(K)Number K050322  
Product Classification Drape, surgical - Product Code KKX
Product Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO.


Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Code Information Lot: D130432, expires February 2018
Recalling Firm/
Manufacturer		 Blue Belt Technologies MN
2905 Northwest Blvd Ste 40
Plymouth MN 55441-2673
For Additional Information Contact Lindsey Brink
763-452-4922
Manufacturer Reason
for Recall		 Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
FDA Determined
Cause 2		 Package design/selection
Action Blue Belt Technologies contacted consignees by telephone using a script on July 19, 2013. The consignees were informed of the problem and the product involved in the recall. Consignees were advised to immediate stop using the product and to locate and quarantine all unused product. Additionally, an "Urgent Medical Device Recall" letter dated July 24, 2013 was issued on July 24, 2013 and August 12, 2013. The letter includes the description of the Issue, description of safety concerns, affected product, and action to be taken by user. For questions contact Blue Belt Technologies, Lindsey Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.
Quantity in Commerce 60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Distribution Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
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 = KKX and Original Applicant = MICROTEK MEDICAL, INC.
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