FDAClass IIAugust 7, 2019

1 pc Full Wrap Support Belt Apron recall

1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F…

Why was 1 pc Full Wrap Support Belt Apron recalled?

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 scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 379682 379535 423744 423745 387796 426462 419802 384492 377568 379681 379690 379698 386085 377724 382991 384347 385884 386083 381755 379715 385640 381868 426861 426802 426955 426895 426634 426809 426951 416567 426461 426789 426952 381869 443767 443802 377712 381865 377711 382966 381899 381866 382876 387805 382949 385982 423502 339345 423501 414165 414167

Product
1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F…
Recalling firm
Burlington Medical, LLC
Quantity
51
Distribution
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Recall date
August 7, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls