FDA Medical Device Recalls (openFDA)
Ferno-Washington Inc: PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.
- Recall number
- Z-0201-06
- Recalling firm
- Ferno-Washington Inc
- Product
- PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.
- Status
- Terminated
- Initiated
- 2003-03-28
- Posted
- 2005-11-26
- Terminated
- 2008-10-29
- Reason
- The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
- Root cause
- Other
- Action
- The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.
- Quantity
- 2188 total stretchers
- Distribution
- The product was distributed nationwide to 27 states: TN, MA, VT, IL, KY, NY, SC, WI, TX, MO, NH, CO, GA, NC, CA, VA, IA, PA, CT, OH, NJ, ID, WV, AL, AR, ME and IN.
- Lot, serial or model codes
- All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.
- 510(k) numbers
- ["K862441"]
- PMA numbers
- not on file
- Product code
- FPO
- Firm FEI
- 1523574
- Firm city
- Wilmington
- Firm state
- OH
- 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