Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches
Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage 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: This is an FDA Class II recall involving a potential loss of sterility in a medical device. The hazard is theoretical as no illnesses or injuries are reported, and the affected percentage is small, fitting the criteria for a moderate severity score.
Plain-English summary
Breg Inc is recalling 2,609 units of Dressing Shldr, P/N 04908, distributed nationwide in the United States. These sterile dressings are used as an insulation barrier between the Polar Care cold therapy pad and the skin, typically in post-operative settings.
The recall was initiated because Breg determined that approximately 0.22% of these products may have been sent with unsealed pouches by the contract manufacturer. The source text notes that these pouches may not have been sealed prior to sterilization, meaning products with unsealed pouches will be non-sterile.
Customers are being contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
The recalled product
- Product
- Dressing Shldr, P/N 04908 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
- Manufacturer
- Breg Inc
- 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)
- D163434
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.
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