Home › Barrier Technologies, LLC › Barrier Flex Radiation Protection Apron Vest & Skirt-Pb Free-Small

Barrier Flex Radiation Protection Apron Vest & Skirt-Pb Free-Small

Barrier Technologies, LLC · Model BFVS-PbF-SM · UDI-DI 00850035588482

EAJ

510(k) clearances

114

Adverse events (1 deaths)

Recalls

Facilities

Description

Barrier Flex Vest and Skirt radiation protection apron has an elastic back that provides greater comfort, adjustment and support especially during long procedures. Even weight distribution helps reduce body fatigue and shoulder pads provide additional comfort. Optional elastic insert in skirt affords a more comfortable fit.

Recalls

Date	Firm	Reason
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s
2019-06-07	Burlington Medical, LLC	The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to s

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.