Recall Z-1995-2013 ยท KKX Drape, Surgical, Antimicrobial
Blue Belt Technologies MN
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.
| Date | Aug 21, 2013 (initiated Jul 19, 2013) |
| Status | Terminated |
| 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 |
| Root cause | 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 B |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050322 | MICROTEK EQUIPMENT DRAPES Microtek Medical, Inc., May 17, 2005 |