Home / Recalls / Burlington Medical, LLC / Z-2111-2019

Z-2111-2019 Class II Terminated

Recalled by Burlington Medical, LLC — Newport News, VA

Recall Details

Product Type
Devices
Report Date
August 7, 2019
Initiation Date
June 7, 2019
Termination Date
April 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51

Product Description

1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E, UEF111XLM, UEF111XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Code Information

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

Other recalls by Burlington Medical, LLC

  • Z-2124-2019 Class II — Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, P (June 7, 2019)
  • Z-2113-2019 Class II — Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREV (June 7, 2019)
  • Z-2115-2019 Class II — Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST (June 7, 2019)
  • Z-2130-2019 Class II — Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS (June 7, 2019)
  • Z-2121-2019 Class II — Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2- (June 7, 2019)
  • Z-2107-2019 Class II — Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, (June 7, 2019)
  • Z-2128-2019 Class II — Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products (June 7, 2019)
  • Z-2119-2019 Class II — Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS (June 7, 2019)
  • Z-2110-2019 Class II — Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B (June 7, 2019)
  • Z-2120-2019 Class II — 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Nu (June 7, 2019)