Z-1995-2013Class II

Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO

Name: Z-1995-2013 Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO
Creator: Blue Belt Technologies MN
Published: 2013-07-19
License: https://open.fda.gov/license/

Blue Belt Technologies MN / initiated 2013-07-19 / Terminated / root cause: packaging

FDA source

Blue Belt Technologies MN began a recall of 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... on 2013-07-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1995-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Posted: 2013-08-21
Terminated: 2013-11-14
Recalling firm: Blue Belt Technologies MN
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.
Product code: KKX Drape, Surgical, Antimicrobial
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
Root cause tag: packaging
FDA 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 Bring (+1 763.452.4922) or Robin Gonzalez (+1 763.452.4910) and get a Return Authorization number. Lindsey or Robin will arrange a pickup of the product. BBT will send replacement product at no charge.
Quantity in commerce: 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.
Product codes and lots: Lot: D130432, expires February 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1995-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1995-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-21

Product code KKX

K050322Class IIMicrotek Equipment DrapesMicrotek Medical, Inc. / cleared 2005-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)