Blue Belt Technologies Recalls Sterile Monitor Drapes for Navio PFS System
Blue Belt Technologies is recalling sterile monitor drapes used with the Navio PFS system during orthopedic knee surgery because the front section separates from the rest of the drape.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The defect compromises the sterile barrier, creating a risk of contamination and infection, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Blue Belt Technologies is recalling sterile Monitor Drapes (REF: PFSD-V0001) used with their Navio PFS system during orthopedic knee surgery. The drapes are intended to cover the Navio PFS system computer monitor and arm assembly to provide a sterile barrier in the surgical suite.
The recall is due to a defect where the front section of the drape separates from the rest of the drape when the computer monitor is being draped. This defect compromises the sterile barrier function of the device.
The affected units are Lot D130432, which expires in February 2018. The recall involves 60 cartons (20 pieces per carton), with 40 units distributed in the EU and 20 in the US. Distribution was worldwide, including the United Kingdom, and nationwide in the US states of California and Pennsylvania. Healthcare facilities should stop using the affected drapes and contact Blue Belt Technologies for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Blue Belt Technologies MN
- Category
- Medical Device — Surgical Drapes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: D130432
- expires February 2018
Distribution
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