Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall If Hip, Sterile Polar Dressing

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall If Hip, Sterile Polar Dressing see related information
Date Initiated by Firm March 30, 2017
Date Posted May 02, 2017
Recall Status1 Terminated 3 on June 23, 2017
Recall Number Z-1908-2017
Recall Event ID 76994
Product Classification Tape and bandage, adhesive - Product Code KGX
Product If Hip, Sterile Polar Dressing P/N 10680

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.
Code Information D163444
Recalling Firm/
Manufacturer		 Breg Inc
2885 Loker Ave E
Carlsbad CA 92010-6626
For Additional Information Contact
760-795-5440
Manufacturer Reason
for Recall		 They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
FDA Determined
Cause 2		 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 in Commerce 2,609 units total
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-