Breg Inc: 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 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. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

Recall number

Z-1905-2017

Recalling firm

Breg Inc

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

Status

Terminated

Initiated

2017-03-30

Posted

2017-05-02

Terminated

2017-06-23

Reason

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Root cause

Employee error

Action

Breg sent an Urgent Medical Device Correction Letter to customers on 4/13/17. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: Please take the following actions: 1) Determine if any potentially affected products are in your stock by comparing each product's Lot and Date to the Lot Numbers and Expiration Dates in the table above. Refer to Picture 2 for the location of these fields on the product packaging. 2) Once you have matched Lot and Date, inspect the product to identify any open (unsealed) pouches. Refer to Picture 1 below. 3) Remove any open pouches from your inventory and discard. 4) Complete the Response Form included as Attachment A, and email or fax to Breg as follows: a. E-mail: bregfieldcorrection@breg.com: Subject: Sterile Dressing Correction b. Fax: 800-FAX-BREG (329-2734)- Subject: Sterile Dressing Correction Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.

Quantity

2,609 units total

Distribution

US Nationwide Distribution

Lot, serial or model codes

D163434

510(k) numbers

not on file

PMA numbers

not on file

Product code

KGX

Firm FEI

1000125378

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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