Recall Z-1904-2017 ยท KGX Tape And Bandage, Adhesive
Breg Inc
Dressing, Knee L/XL, P/N 04708 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
| Date | May 2, 2017 (initiated Mar 30, 2017) |
| Status | Terminated |
| 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) R |
| Quantity | 2,609 units total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.