| Date Initiated by Firm | April 19, 2005 |
|---|
| Date Posted | June 25, 2005 |
|---|
| Recall Status1 |
Terminated 3 on October 03, 2006 |
| Recall Number | Z-0931-05 |
|---|
| Recall Event ID |
31998 |
| Product Classification |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene - Product Code DXZ
|
| Product | PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811,
M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. |
|---|
| Code Information |
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113. |
| FEI Number |
3002095335
|
Recalling Firm/
Manufacturer |
Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
|
| For Additional Information Contact | Jennifer Bolton
763-494-1163 |
|---|
Manufacturer Reason
for Recall | Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products. |
|---|
| Quantity in Commerce | 290 packs containing 5 pieces of Felt. |
|---|
| Distribution | The product was distributed to hospitals nationwide. |
|---|
| 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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