Home / Recalls / Breg Inc / Z-1906-2017

Z-1906-2017 Class II Terminated

Recalled by Breg Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
March 30, 2017
Termination Date
June 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,609 units total

Product Description

Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

Reason for Recall

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Distribution Pattern

US Nationwide Distribution

Code Information

D163544

Other recalls by Breg Inc

  • Z-0231-2024 Class II — BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking a (September 13, 2023)
  • Z-1905-2017 Class II — Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressing (March 30, 2017)
  • Z-1901-2017 Class II — Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dre (March 30, 2017)
  • Z-1903-2017 Class II — Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressin (March 30, 2017)
  • Z-1907-2017 Class II — Dressing Back, P/N 09810 Product Usage: These products are sterile dressings (March 30, 2017)
  • Z-1908-2017 Class II — If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are s (March 30, 2017)
  • Z-1904-2017 Class II — Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dre (March 30, 2017)
  • Z-1902-2017 Class II — Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressin (March 30, 2017)
  • Z-1447-2014 Class II — K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product (March 14, 2014)
  • Z-1446-2014 Class II — Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: (March 14, 2014)