Home / Recalls / Burlington Medical, LLC / Z-2129-2019

Z-2129-2019 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
9

Product Description

Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 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: 419886 443251 426551 443014 444704 416997 391132 419882 419877

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)