Z-1908-2017Class II
If Hip, Sterile Polar Dressing P/N 10680
Breg Inc / initiated 2017-03-30 / Terminated / root cause: manufacturing process
Breg Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1908-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Breg Inc
- 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.
- Product code
- KGX Tape And Bandage, Adhesive
- Reason for recall
- They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Root cause tag
- manufacturing process
- FDA 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) 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: [email protected]: 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
- Product codes and lots
- D163444
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1901-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1902-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1903-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1904-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1905-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1906-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1907-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1908-2017 | Class II | Terminated | Voluntary: Firm initiated |
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