| Date Initiated by Firm | January 08, 2003 |
|---|
| Date Posted | January 30, 2003 |
|---|
| Recall Status1 |
Terminated 3 on May 01, 2012 |
| Recall Number | Z-0487-03 |
|---|
| Recall Event ID |
25224 |
| 510(K)Number | K923922 |
|---|
| Product Classification |
Sponge, Ophthalmic - Product Code HOZ
|
| Product | Ultrakleen KSponge II Spears
Catalog #: K20-5012 |
|---|
| Code Information |
Lot Number: 063207 Exp. 10/2005 |
Recalling Firm/
Manufacturer |
Ultracell Medical Technologies
183 Providence
North Stonington CT 06359
|
| For Additional Information Contact | Audrey Vitale
860-599-4883 |
|---|
Manufacturer Reason
for Recall | Sterility of the device is compromised |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts. |
|---|
| Quantity in Commerce | 4,047 units |
|---|
| 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 = HOZ
|
|---|
