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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KKX
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