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Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy… recallZ-2174-2012 · Nellcor Puritan Bennett Inc. (dba Covidien LP) · initiated Jul 18, 2012

Class I Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nellcor Puritan Bennett Inc. (dba Covidien LP) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2174-2012
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jul 18, 2012
Posted by the FDA
Aug 10, 2012
Recalling firm
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Quantity
337,227 units
Product code
JOH
FDA submissions
K962173
Distribution
Worldwide Distribution - US Nationwide

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

52 devices cleared under K962173 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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