| Date Initiated by Firm | August 08, 2017 |
|---|
| Date Posted | August 25, 2017 |
|---|
| Recall Status1 |
Terminated 3 on August 05, 2019 |
| Recall Number | Z-0053-2018 |
|---|
| Recall Event ID |
77965 |
| 510(K)Number | K880961 |
|---|
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Alcon Custom Pak |
|---|
| Code Information |
2033459H, 2034186H, 2034491H |
| FEI Number |
1000117501
|
Recalling Firm/
Manufacturer |
Alcon Research, LTD.
9965 Buffalo Speedway
Houston
TX
77054-1309
|
| For Additional Information Contact | Bill Walker
800-862-5266 |
|---|
Manufacturer Reason
for Recall | Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon.
Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction. |
|---|
| Quantity in Commerce | 33 units |
|---|
| Distribution | States in the US - WI, NY, MO |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = LRO
|
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