FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare, Ltd.: Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
- Recall number
- Z-0621-2013
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-19
- Posted
- 2013-01-03
- Terminated
- 2013-07-11
- Reason
- 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
- 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
- 200 units total, 26 units US
- Distribution
- Worldwide Distribution - USA including IL, IN, AR and GA.
- Lot, serial or model codes
- Lots 110810 and 111020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZO
- Firm FEI
- 3002806988
- Firm city
- North Shore City
- Firm state
- East Tamaki
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28