FDA-Device2017-05-10Class II
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 inst
Breg Inc
Hazard
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Sold states
US Nationwide Distribution
Affected count
2,609 units total
Manufactured in
2885 Loker Ave E, Carlsbad, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2017Don't want to check this manually?
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