Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen th

FDA device recall Z-0621-2013 · posted 2013-01-03 · Terminated

Recall details

Recalling firm

Fisher & Paykel Healthcare, Ltd.

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

Action taken

Fisher & Paykel sent an Urgent Medical Device Recall letter dated November 19, 2012, with a Product Recall Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and discard any affected circuits in their possession. Customers were instructed to complete and return the Product Recall Response form to the address indicated on the form, even if they have no affected product. Customers were asked to forward the recall notice to all those who need to be aware within their organization. Customers with questions should call 1-800-792-3912. For questions regarding this recall call 949-443-4095.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BZO

Quantity affected

200 units total, 26 units US

Distribution

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

Date initiated

2012-11-19

Date posted

2013-01-03

Date terminated

2013-07-11

Location

North Shore City, East Tamaki, New Zealand