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A10

BURLINGTON MEDICAL, LLC · Model RTLA10-SM · UDI-DI 00840331210491

EAJ

510(k) clearances

114

Adverse events (1 deaths)

Recalls

Facilities

Description

RTLA10-SM (A10: Frontal Apron with crisscross stretch back .5MM TRUELITE, SM)

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.