Z-0621-2013Class I

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

Name: Z-0621-2013 Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in...
Creator: Fisher & Paykel Healthcare, Ltd.
Published: 2012-11-19
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2012-11-19 / Terminated / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare, Ltd. began a recall of Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient on 2012-11-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0621-2013
Classification: Class I
Status: Terminated
Initiated: 2012-11-19
Posted: 2013-01-03
Terminated: 2013-07-11
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: 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 code: BZO Set, Tubing And Support, Ventilator (W Harness)
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 200 units total, 26 units US
Distribution: Worldwide Distribution - USA including IL, IN, AR and GA.
Product codes and lots: Lots 110810 and 111020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0621-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0621-2013	Class I	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)