CLASS I Device recall · Reported 22 Aug 2012 · FDA Enforcement Report
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes recalled
Nellcor Puritan Bennett Inc. ( is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, distributed nationwide in the US. The recall was initiated on 18 Jul 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2174-2012
- FDA event ID
- 62559
- Recalling firm
- Nellcor Puritan Bennett Inc. (, Boulder, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Jul 2012
- FDA classified
- 10 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 18 Jul 2012 | Recall initiated by company | |
| 10 Aug 2012 | Classified by FDA | +23 days |
| 22 Aug 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nellcor Puritan Bennett Inc. (
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Covidien Puritan Bennett 980 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Other | Nationwide |
| Device | CLASS I | Covidien Puritan Bennett 980 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 17 states |
| Device | CLASS II | Vital Sync RMS 1.0 when loaded with v2.4 recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 8 states |
| Device | CLASS II | Vital Sync" VPMP & IM recalled by Nellcor Puritan Bennett Inc. ( | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 8 states |
| Device | CLASS II | Puritan Bennett 840 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |