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Barrier Wrap with Support - PbFree - Extra Small

Barrier Technologies, LLC · Model BWSP-PbF-XS · UDI-DI 00850035588901

EAJ

510(k) clearances

115

Adverse events (1 deaths)

Recalls

Facilities

Description

Barrier Wrap with Support Apron. Provides full wrap around protection against direct & scatter radiation. One-piece design enables easy-on & easy-off. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region. UltraFlex material.

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.