Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FE

FDA device recall Z-2174-2012 · posted 2012-08-10 · Terminated

Recall details

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Reason for recall

Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.

Action taken

Covidien sent an Urgent Medical Device Recall letter dated July 18, 2012 to all affected consignees via mail (FedEx) notification. The customer communication identified the affected product , problem and actions to be taken. Customers were instructed to examine their inventory, segregate product with the identified affected product codes and lot numbers and complete the enclosed verification form and fax to 925-463-4600. Customers were asked to return unused products from the affected product codes and lots. The firm also recommended the replacement of affected tubes that were already in use as soon as clinically appropriate. The letter stated to return the affected product for credit or question contact Technical Services group at 800-635-5267 option 3, option 1 and reference the Return Goods Authorization number.

Root cause

Device Design

Status

Terminated

Product code

JOH

Quantity affected

337,227 units

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2012-07-18

Date posted

2012-08-10

Date terminated

2015-01-22

Location

Boulder, CO

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