The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1901-2017·Announced 2017-05-10

Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage 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 3/5 (High).

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 the loss of sterility in a medical device, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Breg Inc is recalling sterile dressings (P/N 02328) used as an insulation barrier between the Polar Care cold therapy pad and the skin. These products are typically applied in a non-sterile environment after post-op procedures, but on occasion may be applied in a sterile environment.

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

The recalled product

Product
Dressing Knee/Shldr, P/N 02328 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

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.

See all 8 products in this recall →

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