Agency classClass IIOur severity:High FDA (Devices)·Z-2826-2015·Announced 2015-10-07

Ferno iNX Wheeled Stretcher Recalled for Telescoping Load Frame Defect

Ferno-Washington Inc is recalling 72 Ferno iNX Wheeled Stretchers because hole elongation in the load frame may allow the retention pin to move.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that could lead to patient harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ferno-Washington Inc is recalling 72 units of the Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System. The recall is due to a defect where hole elongation in the telescoping load frame channel could affect the ability of the retention pin to stay seated. This retention is necessary to preclude movement of the telescoping load frame.

The affected stretchers are used for pre-hospital patient transport. The units were distributed worldwide, including in the United States (CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA, WY) and in Canada, Australia, the United Kingdom, and New Zealand. Specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities and users should stop using the affected stretchers and contact Ferno-Washington Inc for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.

The recalled product

Product: Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport.
Manufacturer: Ferno-Washington Inc
Category: Medical Device — Patient Transport
Hazard: structural-defect
patient-fall
Affected units: 72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial #s: 15F001703
15F001704
15F001706
15F001707
15F001708
15F001709
15F001710
15F001711
15F001712
15F001713
15F001715
15F001717
15F001719
15F001721
15F001722
15F001723
15F001724
15F001725
15F001726
15F001727

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Ferno-Washington Inc

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