Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheostomy Tubes
June 23 2015 - 5:00PM
DUBLIN - June 23, 2015 - Medtronic (NYSE: MDT) announced that on
May 8, 2015, it began notifying hospitals and distributors
worldwide that affected lots of its Covidien Shiley(TM)
tracheostomy tubes were formed with a wider-angle bend than
standard models manufactured after November 29, 2012.
The company initiated the field action following a
small number of customer complaints that included reports
of 12 serious patient injuries, such as breathing difficulties
that impacted oxygen levels immediately upon tube placement or
discomfort. Replacement of the tracheostomy tube with product
manufactured prior to November 29, 2012 addressed the patient
breathing difficulty or discomfort. The notification requested all
customers and distributors to quarantine and discontinue use of all
potentially affected units and return the affected product to the
company as soon as possible for credit.
Customers and distributors, who have provided the
recalled Shiley tracheostomy tubes to a homecare provider or
patient, must notify the primary care physician and the homecare
provider that these products should be discontinued from use and
returned. If one of the recalled products is currently in use
in a homecare patient, and the patient is not experiencing any
discomfort, breathing difficulties or any other issues related to
the tube, it is recommended that the patient's physician evaluate
the continued use. If the physician advises leaving the
tracheostomy tube in place, the tube must be replaced with an
alternate device at the next tube exchange.
Medtronic also took the necessary steps to prevent
future shipments of the recalled products. The company also
notified regulatory agencies around the world, as
appropriate. Since November 29, 2012, Shiley tracheostomy
tubes were shipped into Australia, Belgium, Canada, Chile, Germany,
Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa,
Turkey, Uruguay and the United States of America.
A Shiley tracheostomy tube is put through a
patient's trachea (windpipe) during a tracheostomy procedure to
help provide an airway and facilitate the ability to breathe.
The recall includes specific lots from the
following eight product lines that were manufactured after November
29, 2012.
The recall is limited to the product codes and
associated lot numbers listed in the table below. If you are unable
to determine the lot number of any of the product codes and size
listed in the table, then those products should be treated as if
they are within the affected lot numbers.
Lot numbers will appear on the product labeling and the number is
structured with the first two digits representing the year of
manufacturing, i.e., 12 is for 2012, 13 is for 2013 and 14 is for
2014. |
Cuffless Products |
Product Description Name |
Product Numbers |
Lot |
Shiley Neonatal Tracheostomy Tube Cuffless |
2.5NEF |
All lot numbers beginning with 12, 13 and 14 |
3.0NEF |
3.5NEF |
4.0NEF |
4.5NEF |
Shiley Pediatric Tracheostomy Tube Cuffless |
2.5PEF |
All lot numbers beginning with 12, 13 and 14 |
3.0PEF |
3.5PEF |
4.0PEF |
4.5PEF |
5.0PEF |
5.5PEF |
Shiley Pediatric Tracheostomy Tube Long Cuffless |
5.0PELF |
All lot numbers beginning with 12, 13 and 14 |
5.5PELF |
6.0PELF |
6.5PELF |
Cuffed Products |
Product Description Name |
Product Numbers |
Lot |
Shiley Neonatal Tracheostomy Tube with TaperGuard(TM)
Cuff
|
2.5NCF |
All lot numbers beginning with 12, 13 and 14 |
3.0NCF |
All lot numbers beginning with 12, 13 and 14; and Lot number
15A0152JZX |
3.5NCF |
All lot numbers beginning with 12, 13 and 14; and Lot number
15A0154JZX |
4.0NCF |
All lot numbers beginning with 12, 13 and 14 |
4.5NCF |
All lot numbers beginning with 12, 13 and 14; and Lot number
15A0155JZX |
Shiley Pediatric Tracheostomy Tube with TaperGuard(TM)
Cuff |
2.5PCF |
All lot numbers beginning with 12, 13 and 14; and Lot number
15A0153JZX |
3.0PCF |
All lot numbers beginning with 12,13 and 14; and Lot
number 15A0151JZX |
3.5PCF |
All lot numbers beginning with 12, 13 and 14
|
4.0PCF |
4.5PCF |
5.0PCF |
5.5PCF |
Shiley Pediatric Tracheostomy Tube Long with TaperGuard(TM)
Cuff
|
5.0PLCF |
All lot numbers beginning with 12, 13 and 14
|
5.5PLCF |
6.0PLCF |
6.5PLCF |
Disposable Bedside Tray (Tray contains 4 units) |
Product Description Name |
Product Numbers |
Lot |
Shiley Neonatal Tracheostomy Tube Cuffless, Disposable
Bedside Tray
|
3.0NEF-P |
All lot numbers beginning with 12, 13 and 14
|
3.5NEF-P |
4.0NEF-P |
4.5NEF-P |
Pediatric Tracheostomy Tube Cuffless, Disposable Bedside
Tray
|
3.0PEF-P |
All lot numbers beginning with 12, 13 and 14
|
3.5PEF-P |
4.0PEF-P |
4.5PEF-P |
5.0PEF-P |
5.5PEF-P |
Adverse reactions or quality problems experienced
with the use of this product may be reported to the FDA's MedWatch
Adverse Event Reporting program either online, by regular mail or
by fax.
-
Complete and submit the report
Online: www.fda.gov/medwatch/report.htm
-
Regular Mail or
Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to 1-800-FDA-0178
or
- Email Medtronic Post Market Vigilance at:
HQTSWEB@COVIDIEN.COM Call Medtronic Post Market Vigilance at:
800-635-5267 option 1, option 1, and again option 1. The call
center hours of operation are 6:00am - 4:00pm Pacific time, Monday
- Friday. Customers have an option to leave a message after
hours.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Contacts:
John Jordan
Public Relations
+1-508-452-4891
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
HUG#1929999
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