Cuffed Shiley Tracheostomy Products - Health Canada Endorsed Important Safety Information - Notice to Hospitals

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Contact: Marketed Health Products Directorate

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This is duplicated text of a letter from Tyco Healthcare Canada.
Contact the company for a copy of any references, attachments or enclosures.

Notice to Hospitals
Health Canada Endorsed Important Safety Information on Certain Cuffed Shiley Tracheostomy Products

April 15, 2010

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Emergency Medecine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required, and other involved professional staff and post this notice in your institution.

Subject: Urgent medical device recall on Certain Cuffed Shiley™ Tracheostomy Products

Tyco Healthcare Canada has received customer reports of serious adverse health consequences that may be linked to certain cuffed Shiley™ tracheostomy tubes, in which the cuff does not hold air as a result of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected and the tracheostomy tube might require immediate replacement. Accordingly, we have voluntarily determined that Shiley™ Tracheostomy Products from affected lot numbers should be returned. 

Please review your inventory and segregate any product with the affected lot numbers. Unused affected product should be returned according to the directions below.

If a cuffed Shiley™ tracheostomy tube from an affected lot is already in use in a patient, we recommend that the tube be replaced with a tube that is not included in the affected lots as soon as the patient's physician determines it is clinically appropriate. If the physician advises leaving the tracheostomy tube in place until a more acceptable replacement opportunity occurs, we strongly advise that the frequency and intensity of monitoring the cuff inflation system be increased.

The recall applies to the 37 product codes and associated lot numbers listed in the Tables 1 and 2 below. Lot numbers are configured as follows - YYMMXXXXXX where YY is the year, MM is the month, XXXXXX is a sequential number. Please note the additional information following each table.

Table 1 - Shiley™ Tracheostomy Products

Item	Starting Lot Number	Ending Lot Number
4DCT	0810002426	0908000766
6DCT	0810002428	0908000773
8DCT	0810002433	0908000787
10DCT	0811000171	0908000765
4LPC	0810002441	0908000768
6LPC	0810002442	0908000780
8LPC	0810000069	0908000792
10LPC	0811001521	0907001560
4.0PDC	0903000859	0908001790
4.5PDC	0903000861	0908000693
5.0PDC	0903000862	0908001208
5.5PDC	0903000863	0908001211
4FEN	0811001522	0908000767
6FEN	0810002445	0908000776
8FEN	0810002447	0908000256
10FEN	0811001364	0908000233
4DFEN	0811001526	0908000235
6DFEN	0810002448	0908000774
8DFEN	0811000185	0908000789
10DFEN	0812000028	0908000232
5SCT	0906000823	0907001067
6SCT	0903001835	0908000124
7SCT	0903000809	0908002300
8SCT	0903000810	0908001215
9SCT	0905001770	0907001068
10SCT	0907002007	0908001339
6PERC	0810002450	0908000782
8PERC	0810002453	0908000797
5.0PLC	0903000865	0907001065
5.5PLC	0903001839	0907001066
6.0PLC	0903000866	0908001213
6.5PLC	0903000867	0907001525

For the products listed in Table 1 above:

• Products with lot codes where the first four numbers are in the range from 0810 to 0908 may be affected; consult Table 1 for specific lot code ranges for each product code.
• Products in the above Table 1 with lot code numbers starting with 0809 or lower, and those with lot code numbers starting with 0909 or higher, are not affected.

Table 2 - Custom Shiley™ Tracheostomy Products

Item	Starting Lot Number	Ending Lot Number
MSCT	0904000093	0912001647
MPDC	0904001545	0905000593
MDCT	0911000199	0911000221
MLPC	0908001982	0912000321
MFEN	0908001420	0912000048

For the products listed in Table 2 above:

• Products with lot codes where the first four numbers are in the range from 0904 to 0912 may be affected; consult Table 2 for specific lot code ranges for each product code.
• Products in the above Table 2 with lot code numbers starting with 0903 or lower, and those with lot code numbers starting with 1001 or higher, are not affected.

To locate Lot numbers:

• The lot number for all Shiley™ dual cannula tracheostomy tubes is clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch in which the product was shipped.
• The lot number for all single cannula Shiley™ tracheostomy tubes is clearly printed on the carton and on the package tray lid.
• The lot number of Custom/Specialty Tracheostomy tubes is printed on the pouch or tray lid, depending upon the product configuration.
• If you need assistance locating the lot number, please contact your local Sales Representative. If you are unable to determine the lot number of the cuffed Shiley™ tracheostomy tube, these products should be treated as if they are within the affected lot numbers and you should proceed as directed below.

Should you have any affected product, please contact Tyco Healthcare (1-877-664-8926) to arrange for product return and credit.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any case of serious specific adverse incident or other serious or unexpected adverse incidents for medical devices in patients using Cuffed Shiley™ Tracheostomy Tubes should be reported to Tyco Healthcare Canada or Health Canada at the following addresses:

original signed by

Joseph Di Marzo
Director, Regulatory Affairs and Quality Assurance