KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Clos

FDA device recall Z-1678-2015 · posted 2015-05-26 · Terminated

Recall details

Recalling firm

Halyard Health, Inc

Reason for recall

The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit.

Action taken

Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.

Root cause

Device Design

Status

Terminated

Product code

BSY

Quantity affected

11 cases each containing 20 individual endotracheal tubes

Distribution

Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.

Date initiated

2015-04-14

Date posted

2015-05-26

Date terminated

2015-07-07

Location

Alpharetta, GA