Fisher & Paykel Healthcare, Ltd.: Medical Device Recall in 2013 - (Recall #: Z-0621-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

Product Classification:

Class I

Date Initiated: November 19, 2012

Date Posted: January 9, 2013

Recall Number: Z-0621-2013

Event ID: 63794

Reason for Recall:

FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int

Status: Terminated

Product Quantity: 200 units total, 26 units US

Code Information:

Lots 110810 and 111020

Distribution Pattern:

Worldwide Distribution - USA including IL, IN, AR and GA.

Voluntary or Mandated:

Voluntary: Firm initiated