The Recall Desk
ModerateFDA (Devices)·Z-1906-2017·Announced 2017-05-10

Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads

Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device. No illnesses or injuries are reported in the source text, and the defect affects a small percentage of units, fitting the criteria for a moderate severity rating.

Plain-English summary

Breg Inc is recalling 2,609 units of Dressing Shldr XL (P/N 04918), sterile dressings used as an insulation barrier between Polar Care cold therapy pads and the skin. The recall is due to a manufacturing defect where a small percentage of the products may have been sent with unsealed pouches by the contract manufacturer.

Products with unsealed pouches may not have been sealed prior to sterilization, meaning they are non-sterile. These dressings are typically applied in a non-sterile environment after post-operative procedures, but on occasion may be applied in a sterile environment. The affected products were distributed nationwide in the United States.

Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

The recalled product

Product
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 appli
Manufacturer
Breg Inc
Category
Medical Device — Sterile Dressings
Hazard
Affected units
2,609

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • D163544

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Breg Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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