Home / Recalls / Burlington Medical, LLC / Z-2110-2019

Z-2110-2019 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
23

Product Description

Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM 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: 381792 385576 423909 381833 385669 385700 381810 423908 423907 423936 423938 423910 423939 423906 423913 385705 423627 385664 385671 379711 385670 423911 423915

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-2116-2019 Class II — 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK* (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)