FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett Inc. (dba Covidien LP): Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
- Recall number
- Z-2174-2012
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Product
- Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
- Status
- Terminated
- Initiated
- 2012-07-18
- Posted
- 2012-08-10
- Terminated
- 2015-01-22
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 337,227 units
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X. Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.
- 510(k) numbers
- ["K962173"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28