| Date Initiated by Firm | June 06, 2003 |
|---|
| Date Posted | July 02, 2003 |
|---|
| Recall Status1 |
Terminated 3 on July 02, 2004 |
| Recall Number | Z-0968-03 |
|---|
| Recall Event ID |
26475 |
| 510(K)Number | K021044 |
|---|
| Product Classification |
Introducer, Catheter - Product Code DYB
|
| Product | Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 |
|---|
| Code Information |
Lot Number W24540 |
Recalling Firm/
Manufacturer |
MedAmicus,Inc
15301 Highway 55 West
Plymouth MN 55447
|
| For Additional Information Contact | Karyl Haskell
763-577-2257 |
|---|
Manufacturer Reason
for Recall | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products. |
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| Distribution | The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts. |
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| 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 = DYB
|
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