| Date Initiated by Firm | July 31, 2006 |
|---|
| Date Posted | September 27, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 10, 2007 |
| Recall Number | Z-1531-06 |
|---|
| Recall Event ID |
36268 |
| 510(K)Number | K840568 |
|---|
| Product Classification |
ostomy pouch - Product Code LNO
|
| Product | ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15)
1 3/4 in. 45 mm |
|---|
| Code Information |
REF 175772; UPC 00031 75772; Lot # 6E3586N |
Recalling Firm/
Manufacturer |
ConvaTec
200 Headquarters Park Dr
Skillman NJ 08558-2624
|
| For Additional Information Contact | Karen Krenta
908-904-2071 |
|---|
Manufacturer Reason
for Recall | Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.
|
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | A recall notification was mailed by first class mail on 7/31/2006 to all direct customers with letter to tier 1 distributors for tier 2 end users. |
|---|
| Distribution | Nationwide |
|---|
|
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 = LNO
|
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