Device recall: Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of…
Class II FDA enforcement event 65834. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Blue Belt Technologies MN started this device recall on 19 Jul 2013. The firm address in the FDA record is in Plymouth, MN. FDA put the recall in Class II. FDA event 65834 has 1 product record. The first FDA enforcement report date is 28 Aug 2013. The record gives the status Terminated, with the termination date 14 Nov 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Recalling firm
Blue Belt Technologies MN, Plymouth, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1995-2013 | 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. | 60 cartons (20 pieces/carton) 40 in EU, 20 in US. | Class II | Terminated | 28 Aug 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2014 | Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. | Device | Class II | 2 |
| 11 Apr 2014 | NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1995-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 65834. https://recallregister.com/fda/ii/65834/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
- What quantity of product is in FDA event 65834?
- The FDA record gives this quantity:
60 cartons (20 pieces/carton) 40 in EU, 20 in US.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.