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Terminated

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

FDA Recall Z-0202-06 · Posted 2005-11-26

Recalling FirmFerno-Washington Inc
Recall StatusTerminated
Product CodeFPO
Date Initiated2003-03-28
Date Terminated2008-10-29
Product Quantity2188 total stretchers

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K862441EZ LOAD MODEL 30, ALL LEVEL COTFerno-Washington, Inc. · 1986-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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