| Date Initiated by Firm | March 30, 2006 |
|---|
| Date Posted | April 19, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 09, 2006 |
| Recall Number | Z-0777-06 |
|---|
| Recall Event ID |
35123 |
| Product Classification |
General Surgery Tray - Product Code LRO
|
| Product | Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China |
|---|
| Code Information |
Reorder number DYNJP1047, lot 5149116 |
Recalling Firm/
Manufacturer |
Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
|
| For Additional Information Contact | Customer Service
800-633-5463 |
|---|
Manufacturer Reason
for Recall | The product may not be sterile. The pouches were damaged during sterilization. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline. |
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| Quantity in Commerce | 21 cases |
|---|
| Distribution | Texas |
|---|
| 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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