The Recall Desk
HighFDA (Devices)·Z-1903-2017·Announced 2017-05-10

Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves non-sterile medical dressings, which poses a risk of harm (infection) to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Breg Inc is recalling 2,609 units of Dressing Rect L, P/N 02428. These sterile dressings are used as an insulation barrier between the Polar Care cold therapy pad and the skin. The products were distributed nationwide in the United States.

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 non-sterile.

Customers are being contacted and instructed to inspect their inventory for any product with unsealed pouches. Any affected units should be discarded.

The recalled product

Product
Dressing Rect L, P/N 02428 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
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 (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 →

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Same hazard · non sterile

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