Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this

FDA device recall Z-1995-2013 · posted 2013-08-21 · Terminated

Recall details

Recalling firm

Blue Belt Technologies MN

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

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

KKX

Quantity affected

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.

Date initiated

2013-07-19

Date posted

2013-08-21

Date terminated

2013-11-14

Location

Plymouth, MN

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