| Date Initiated by Firm | April 17, 2007 |
|---|
| Date Posted | July 23, 2007 |
|---|
| Recall Status1 |
Terminated 3 on November 30, 2009 |
| Recall Number | Z-1062-2007 |
|---|
| Recall Event ID |
37778 |
| 510(K)Number | K032671 |
|---|
| Product Classification |
Topical anesthetic skin refrigerant - Product Code MLY
|
| Product | Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01) |
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| Code Information |
Lot number 9253 expires 11-08 |
Recalling Firm/
Manufacturer |
Gebauer Company
4444 E 153rd St
Cleveland OH 44128
|
| For Additional Information Contact | Amy J Paukovits
216-581-3030 Ext. 120 |
|---|
Manufacturer Reason
for Recall | Mold contamination |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm sent a recall letter dated April 17, 2007 to all customers. |
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| Quantity in Commerce | 1,824 cans of product |
|---|
| Distribution | Nationwide |
|---|
| 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 = MLY
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