Home › Barrier Technologies, LLC › Barrier Flex Radiation Protection Apron-Pb Free-Large

Barrier Flex Radiation Protection Apron-Pb Free-Large

Barrier Technologies, LLC · Model BF-PbF-LG · UDI-DI 00850035588451

EAJ

510(k) clearances

114

Adverse events (1 deaths)

Recalls

Facilities

Description

The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable Velcro straps cross in the back and attach in the front providing a comfortable fit while keeping the apron securely on the shoulders. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Comfortable fit during long procedures. Shoulder pads provide additional comfort.

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.