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F132

BURLINGTON MEDICAL, LLC · Model STLF111-XSF · UDI-DI 00840331203608

EAJ
6
510(k) clearances
114
Adverse events (1 deaths)
25
Recalls
29
Facilities

Description

STLF111-XSF (F111: 1 Piece Wrap Around with Wide Stretch Belt .35MM TRUELITE, XSF)

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.