The Recall Desk
HighFDA (Devices)·Z-0739-2017·Announced 2016-12-21

Stryker Recalls Performance-LOAD Ambulance Cot Fasteners Due to Fastening Issues

Stryker is voluntarily recalling 749 Performance-LOAD Ambulance Cot Fasteners because they may not fasten securely, posing a risk of injury.

What this means for you

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 risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria for medical devices.

Plain-English summary

Stryker Medical Division of Stryker Corporation has initiated a voluntary recall of 749 units of Performance-LOAD Ambulance Cot Fasteners. The affected models are 6392-000-001, 6392-000-002, 6393-000-003, and 6393-000-004. These products were distributed worldwide to numerous U.S. states, as well as to Canada and the Netherlands.

The recall was initiated due to complaints that the fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD. Additionally, the fasteners may bounce back during loading. These defects could cause injury to consumers.

Consumers who possess these specific fasteners should stop using them and contact Stryker Medical for further instructions on the recall process.

The recalled product

Product
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
Affected units
749

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 (8)

  • Model(s): 6392-000-001
  • 6392-000-002
  • 6393-000-003
  • 6393-000-004
  • GTIN: 07613327282542
  • 07613327282603
  • 07613327282597
  • 07613327282610

Distribution