PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550.
FDA device recall Z-0202-06 · posted 2005-11-26 · Terminated
Recall details
- Recalling firm
- Ferno-Washington Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPO
- Quantity affected
- 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.
- Date initiated
- 2003-03-28
- Date posted
- 2005-11-26
- Date terminated
- 2008-10-29
- Location
- Wilmington, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EZ LOAD MODEL 30, ALL LEVEL COT (K862441) | Ferno-Washington, Inc. | 1986-09-12 |