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.
This recall has been terminated (originally issued May 2, 2017).
- Company
- Breg Inc
- Recall Initiated
- March 30, 2017
- Posted
- May 2, 2017
- Terminated
- June 23, 2017
- Recall Number
- Z-1908-2017
- Quantity
- 2,609 units total
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Distribution
US Nationwide Distribution
Lot / Code Info
D163444
Root Cause
Employee error
Action Taken
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.