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Cook recalls tracheostomy equipment

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Cook Medical initiated a voluntary recall of its percutaneous tracheostomy devices that contain a Covidien (NYSE:COV) 6PERC or 8PERC Shiley tube.

According to the Food & Drug Administration, the Bloomington, Ind.-based medical product manufacturer’s recall comprises 17 lots of the ‘Ciaglia Blue Rhino’ and ‘Ciaglia Blue Dolphin’ introducer sets and trays.

In April, Covidien voluntarily recalled some of its Shiley tracheostomy tubes over problems with the devices’ pilot balloons. The Mansfield, Mass.-based medical products giant’s tubes are designed to keep patients’ airways open using small balloons through which breathing tubes pass. Some of the devices can malfunction due to “the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly,” according to the FDA.

The problem could result in sudden decreases in blood oxygen or sudden increases in carbon dioxide in the blood, according to the agency, which in turn could lead to serious injury or death. Covidien sent a letter to customers April 13 detailing the potential problems and instructing them to return any affected products for replacement.

The FDA said Cook mailed a letter to affected Ciaglia customers that detailed the recall. Here’s a list of the affected devices:

Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets/Trays Reorder Number

Global Part  Number

C-PTIS-100-A-HC-PERC8

G12403

C-PTISY-100-A-HC-PERC8

G12566

C-PTIS-100-HC-PERC6

G13165

C-PTIS-100-HC-PERC6-CA

G36037

C-PTISY-100-HC-PERC6

G13166

C-PTIS-100-HC-PERC8

G12523

C-PTIS-100-HC-PERC8-CA

G36038

C-PTISY-100-HC-PERC8

G12565

C-PTISY-100-HC-G-PERC6

G53178

C-PTISY-100-WCE-HC-G-PERC6

G53169

C-PTISY-100-WCE-HC-G-PERC8

G53170

Table 2. Ciaglia Blue Dolphin Products

Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets/Trays Reorder Number

 

Global Part  Number

C-PTBS-2600-PERC6

G36116

C-PTBSY-2600-PERC6

G36118

C-PTBSYJC-2600-PERC6

G51971

C-PTBS-2800-PERC8

G36117

C-PTBSY-2800-PERC8

G49507

C-PTBSYJC-2800-PERC8

G51972

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