| Date Initiated by Firm | July 14, 2005 |
|---|
| Date Posted | August 23, 2005 |
|---|
| Recall Status1 |
Terminated 3 on May 02, 2006 |
| Recall Number | Z-1384-05 |
|---|
| Recall Event ID |
32711 |
| Product Classification |
Aid, Surgical, Viscoelastic - Product Code LZP
|
| Product | Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 59051 |
|---|
| Code Information |
Lot Numbers: CO50510A, C050510 |
Recalling Firm/
Manufacturer |
Anika Therapeutics, Inc.
236 W Cummings Park
Woburn MA 01801-6346
|
| For Additional Information Contact | Tim Mayhew
781-932-6616 Ext. 142 |
|---|
Manufacturer Reason
for Recall | Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Anika Therapeutics notified Distributor accounts by telephone on July 14. The letters were faxed and sent by Fedex on July 14. Distributors were provided with a end-user letter template letter for notification to their accounts. |
|---|
| Quantity in Commerce | 5799 |
|---|
| Distribution | CA, NC |
|---|
| 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.
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