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U.S. Department of Health and Human Services

Class 2 Device Recall PROFlex Transporter, model 35PST.

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 Class 2 Device Recall PROFlex Transporter, model 35PST.see related information
Date Initiated by FirmMarch 28, 2003
Date PostedNovember 26, 2005
Recall Status1 Terminated 3 on October 29, 2008
Recall NumberZ-0201-06
Recall Event ID 34010
510(K)NumberK862441 
Product Classification Stretcher, Wheeled - Product Code FPO
ProductPROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.
Code Information All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information ContactDorothy Deaton
937-382-1451
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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 Commerce2188 total stretchers
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FPO
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