Recall Z-1995-2013— Blue Belt Technologies MN

Name: FDA recall Z-1995-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-19

Class II · Terminated

Class II FDA medical device recall by Blue Belt Technologies MN, initiated 2013-07-19, terminated 2013-11-14. It names one FDA 510(k) clearance: K050322. 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.. Reason: 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.

Recalling firm: Blue Belt Technologies MN
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Terminated: 2013-11-14
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K050322 — MICROTEK EQUIPMENT DRAPESMicrotek Medical, Inc.·cleared 2005-05-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.