| Date Initiated by Firm | October 24, 2017 |
|---|
| Create Date | April 03, 2018 |
|---|
| Recall Status1 |
Terminated 3 on April 17, 2020 |
| Recall Number | Z-1297-2018 |
|---|
| Recall Event ID |
79294 |
| 510(K)Number | K874063 |
|---|
| Product Classification |
Kit, surgical instrument, disposable - Product Code KDD
|
| Product | Large Volume Abdominal Paracentesis Kit |
|---|
| Code Information |
AK 00376 |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
|
| For Additional Information Contact |
610-378-0131 |
|---|
Manufacturer Reason
for Recall | Product packaging may not be completely sealed. |
|---|
FDA Determined
Cause 2 | Component design/selection |
|---|
| Action | On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990 |
|---|
| Quantity in Commerce | 30,577 eaches |
|---|
| Distribution | Nationally |
|---|
| 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 = KDD
|
|---|
