Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1902-2017·Announced 2017-05-10

Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 potential loss of sterility in a small percentage of units, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization reports) or High (high-risk pathogens). It fits the Moderate category for a voluntary precautionary recall addressing a specific defect without reported injuries.

Plain-English summary

Breg Inc is recalling 2,609 units of Dressing M/U XL (P/N 02344) 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 applied in non-sterile environments after post-op procedures, though they may occasionally be used in sterile environments.

The recall is due to a determination by Breg that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Products with unsealed pouches may not have been sealed prior to sterilization and will be non-sterile.

Customers are being contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. The affected lot codes are D163474 and D163544.

The recalled product

Product: Dressing M/U XL, P/N 02344 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…
Manufacturer: Breg Inc
Category: Medical Device — Sterile Dressings
Hazard: loss-of-sterility
packaging-defect
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 (2)

D163474
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 →

Same manufacturer · Breg Inc

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Same hazard · loss of sterility