FDA Medical Device Recalls (openFDA)
Sunrise Medical: 535D-X CF Continuous Flow Cylinder
- Recall number
- Z-0732-2007
- Recalling firm
- Sunrise Medical
- Product
- 535D-X CF Continuous Flow Cylinder
- Status
- Terminated
- Initiated
- 2007-01-24
- Posted
- 2007-04-21
- Terminated
- 2009-08-27
- Reason
- Cylinder could lose oxygen at high pressure after the filling process
- Root cause
- Other
- Action
- The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
- Quantity
- 4,169 units (Z-0731/0732-2007)
- Distribution
- Worldwide-original shipments to distributors/dealers USA and Canada.
- Lot, serial or model codes
- Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
- 510(k) numbers
- ["K020329"]
- PMA numbers
- not on file
- Product code
- NFB
- Firm FEI
- 2515872
- Firm city
- Somerset
- Firm state
- PA
- Firm country
- not on file
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