The Recall Desk
HighFDA (Devices)·Z-2117-2019·Announced 2019-08-07

Burlington Medical Recalls Seven Peak Vests Due to Inadequate Radiation Protection

Burlington Medical is recalling seven Peak Vests because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

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 (radiation protection) where the hazard is theoretical (potential inadequate protection) and no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Burlington Medical, LLC is recalling seven units of the Peak Vest, Single Item (Product Number PVest). The affected units have specific serial numbers and were distributed nationwide in the United States as well as to Korea and Thailand. These vests are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.

The recall was initiated because the protective material used in the manufacture of the products could potentially provide inadequate protection for the user. Use of the products could expose the user to scatter radiation of varying degrees depending on variables such as distance, shielding, position, time, and kV. Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

Healthcare workers who have used these specific vests should stop using them and contact Burlington Medical for further instructions. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
7

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 (1)

  • Serial Numbers: 418892 381887 381902 418811 418952 387916 429678

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 recalled by Burlington Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

Related recalls

Same manufacturer · Burlington Medical, LLC

See all →

Same hazard · radiation exposure

See all →