| Date Initiated by Firm | August 10, 2007 |
|---|
| Date Posted | October 02, 2007 |
|---|
| Recall Status1 |
Terminated 3 on March 07, 2008 |
| Recall Number | Z-0013-2008 |
|---|
| Recall Event ID |
39369 |
| Product Classification |
surgical blade - Product Code GES
|
| Product | Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
|---|
| Code Information |
Reorder number 371211; Lot Number 02028051 -Stainless Steel; Reorder number 371211; Lot Number 02028090- Stainless Steel. |
| FEI Number |
2243072
|
Recalling Firm/
Manufacturer |
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
|
| For Additional Information Contact | Greg Morgan
201-847-4344 |
|---|
Manufacturer Reason
for Recall | Complaints received of rust on the blades of BD Bard-Parker Surgical blades. |
|---|
FDA Determined
Cause 2 | Packaging change control |
|---|
| Action | Urgent recall letters were sent out 8/10/2007 via UPS second day air. |
|---|
| Quantity in Commerce | 56,700 |
|---|
| Distribution | 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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