CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report
Blue Belt Technologies, Inc. Monitor Drape recalled
Blue Belt Technologies MN is recalling Blue Belt Technologies, Inc. Monitor Drape, distributed nationwide in the US. The recall was initiated on 19 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1995-2013
- FDA event ID
- 65834
- Recalling firm
- Blue Belt Technologies MN, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2013
- FDA classified
- 21 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 19 Jul 2013 | Recall initiated by company | |
| 21 Aug 2013 | Classified by FDA | +33 days |
| 28 Aug 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot: D130432, expires February 2018
Where was it sold?
Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Blue Belt Technologies MN
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stride Femoral Component Size 2, Pfsi recalled | Blue Belt Technologies MN | Labeling Errors | Nationwide |
| Device | CLASS II | Stride Femoral Component Size 2, Pfsi recalled | Blue Belt Technologies MN | Labeling Errors | Nationwide |
| Device | CLASS II | NavioPFSTM System, Orthopedic Sterotaxic Instrument recalled | Blue Belt Technologies MN | Device Malfunction | 4 states |
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