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HomeBarrier Technologies, LLC › BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/NB/LG

BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/NB/LG

Barrier Technologies, LLC · Model BWSP-.5mmPbF-LG-UF-NB · UDI-DI 00850035588024

EAJ
6
510(k) clearances
114
Adverse events (1 deaths)
25
Recalls
29
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. Navy Blue, Size Large. Thyroid Collar included.

Recalls

DateFirmReason
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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
2019-06-07Burlington Medical, LLCThe 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.