| Date Initiated by Firm | December 30, 2003 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on January 19, 2006 |
| Recall Number | Z-0638-04 |
|---|
| Recall Event ID |
28388 |
| 510(K)Number | K983819 |
|---|
| Product Classification |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter - Product Code DSY
|
| Product | HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch.
Product Catalog Numbers:
HEK06/75CPUT;
HEK08/75CPUT;
HEK14/75CPUT;
HEK08/120CPUT;
HEK10/75CPUT;
HEK25/100CPUT;
HEK12/75CPUT;
HEK10/150CPUT. |
|---|
| Code Information |
Lot Numbers: 03G03; 03H08; 03J25; 03G10; 03H28; 03K02; 03G17; 03J04; 03K09; 03G24; 03J11; 03K16; 03G31; 03J18; 03K23. |
| FEI Number |
2221819
|
Recalling Firm/
Manufacturer |
Datascope Corporation
14 Philips Pkwy
Montvale NJ 07645-1811
|
| For Additional Information Contact | Mr. Vincent Cafiso
201-307-5476 |
|---|
Manufacturer Reason
for Recall | Water permeability of the patch is out of specification. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall letters were sent to the customers via US Mail return receipt on 12/30/2003. |
|---|
| Quantity in Commerce | 710 units |
|---|
| Distribution | The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives. |
|---|
| 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 = DSY
|
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