Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0202-06

PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550

Ferno-Washington Inc / initiated 2003-03-28 / Terminated

Ferno-Washington Inc began a recall of PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550 on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0202-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ferno-Washington Inc
Product
PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550.
Product code
FPO Stretcher, Wheeled
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.
FDA 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 in commerce
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.
Product codes and lots
All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.