| Date Initiated by Firm | November 07, 2003 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on September 13, 2004 |
| Recall Number | Z-0261-04 |
|---|
| Recall Event ID |
27694 |
| 510(K)Number | K934382 |
|---|
| Product Classification |
Tube, Aspirating, Flexible, Connecting - Product Code BYY
|
| Product | Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand |
|---|
| Code Information |
lots 50904937 and 50904995. |
| FEI Number |
1000115375
|
Recalling Firm/
Manufacturer |
Vital Concepts, Inc.
5090 Kendrick Ct Se
Grand Rapids MI 49512-9649
|
| For Additional Information Contact |
616-954-2890 |
|---|
Manufacturer Reason
for Recall | The probe may separate from the cannula. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field. |
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| Quantity in Commerce | 3045 |
|---|
| Distribution | Arizona, Illinois, Indiana, Michigan and Pennsylvania. |
|---|
| 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 = BYY
|
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