| Date Initiated by Firm | March 11, 2018 |
|---|
| Create Date | May 14, 2018 |
|---|
| Recall Status1 |
Terminated 3 on March 09, 2022 |
| Recall Number | Z-1868-2018 |
|---|
| Recall Event ID |
79886 |
| 510(K)Number | K000180 |
|---|
| Product Classification |
Insufflator, laparoscopic - Product Code HIF
|
| Product | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801.
Used for the transanal endoscopic microsurgery. |
|---|
| Code Information |
Lot numbers: 32062417, 32133317 |
Recalling Firm/
Manufacturer |
Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
|
Manufacturer Reason
for Recall | Tube ends may be mixed up. |
|---|
FDA Determined
Cause 2 | Use error |
|---|
| Action | The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to marek.rast@richard-wolf.com. |
|---|
| Quantity in Commerce | 1710 units |
|---|
| Distribution | Worldwide Distribution |
|---|
| 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 = HIF
|
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