The Recall Desk
ModerateFDA (Devices)·Z-1908-2017·Announced 2017-05-10

Breg Recalls If Hip Sterile Polar Dressings Due to Unsealed Pouches

Breg Inc is recalling 2,609 units of If Hip Sterile Polar Dressings 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. The hazard involves a potential loss of sterility in a medical device, which is a significant quality issue but does not involve reported injuries or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Breg Inc is voluntarily recalling 2,609 units of If Hip Sterile Polar Dressings, Product Number 10680. These sterile dressings are used as an insulation barrier between a Polar Care cold therapy pad and the skin, typically in post-operative settings. The recall was initiated because a small percentage of the products, approximately 0.22%, may have been sent with unsealed pouches by the contract manufacturer.

Products with unsealed pouches may not have been sealed prior to sterilization and are therefore considered non-sterile. The affected products were distributed nationwide in the United States. The specific distribution code associated with this recall is D163444.

Customers have been contacted and instructed to inspect their inventory for any product with unsealed pouches. Any items found to have unsealed pouches should be discarded.

The recalled product

Product
If Hip, Sterile Polar Dressing P/N 10680 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
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)

  • D163444

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 →

Related recalls

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Same hazard · loss of sterility

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