Recall Z-1908-2017— Breg Inc
Class II · Terminated
Class II FDA medical device recall by Breg Inc, initiated 2017-03-30, terminated 2017-06-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile..
- Recalling firm
- Breg Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-30
- Terminated
- 2017-06-23
- Firm location
- Carlsbad, CA, United States
Product description
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.
Reason for recall
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.