Z-2326-2012Class II

Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation...

Name: Z-2326-2012 Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation...
Creator: Breg Inc, An Orthofix Company
Published: 2010-08-11
License: https://open.fda.gov/license/

Breg Inc / initiated 2010-08-11 / Terminated / root cause: manufacturing process

FDA source

Breg Inc, An Orthofix Company began a recall of Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin on 2010-08-11. FDA classified it as Class II and gives the reason as "This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2326-2012
Classification: Class II
Status: Terminated
Initiated: 2010-08-11
Posted: 2012-09-06
Terminated: 2012-09-06
Recalling firm: Breg Inc
Product: Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings. If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.
Quantity in commerce: 502 units
Distribution: Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Product codes and lots: Lot # D101564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2326-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2326-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)