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F111
BURLINGTON MEDICAL, LLC · Model RTLF111-6XM · UDI-DI 00840331209501
6
510(k) clearances
114
Adverse events (1 deaths)
25
Recalls
29
Facilities
Description
RTLF111-6XM (F111: 1 Piece Wrap Around with Wide Stretch Belt .5MM TRUELITE, 6XM)
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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Get your free API keyRead the docsData 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.