| Date Initiated by Firm | October 17, 2017 |
|---|
| Create Date | February 22, 2018 |
|---|
| Recall Status1 |
Terminated 3 on April 21, 2020 |
| Recall Number | Z-0690-2018 |
|---|
| Recall Event ID |
79200 |
| 510(K)Number | K121941 |
|---|
| Product Classification |
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
|
| Product | ARROW PICC
powered by ARROW VPS
Stylet |
|---|
| Code Information |
CDC 34041 VPS Lot# 23F17A0037 23F17B0035 |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
|
| For Additional Information Contact | Customer Service
610-378-0131 |
|---|
Manufacturer Reason
for Recall | The kit may contain an incorrect catheter component. Kits that should
contain a 40cm catheter may contain a 55cm catheter. |
|---|
FDA Determined
Cause 2 | Mixed-up of materials/components |
|---|
| Action | On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990. |
|---|
| Quantity in Commerce | 601 eaches |
|---|
| Distribution | AZ, CA, GA, MA, MO, NY, VA |
|---|
| 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 = LJS
|
|---|
