FDA (Devices) recall action 68493
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were distributed in the US and 12 other countries.
Teleflex Medical is recalling Aquapak SW/EAU Sterile respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Teleflex Medical is recalling 7,758,650 respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Teleflex Medical is recalling Aqua 540 SW and 540 w/040 Adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Teleflex Medical is recalling Aquapak 101 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.