| Date Initiated by Firm | November 08, 2013 |
|---|
| Date Posted | March 10, 2015 |
|---|
| Recall Status1 |
Terminated 3 on March 16, 2015 |
| Recall Number | Z-1259-2015 |
|---|
| Recall Event ID |
70603 |
| 510(K)Number | K021462 |
|---|
| Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
| Product | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB),
8 Fr 40 cc
Model: IAB-05840-LWS |
|---|
| Code Information |
Lot Number: KF1111796 Exp. Date: 11/30/2013 |
Recalling Firm/
Manufacturer |
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
|
| For Additional Information Contact |
610-378-0131 |
|---|
Manufacturer Reason
for Recall | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned. |
|---|
| Quantity in Commerce | 166 units |
|---|
| Distribution | Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany. |
|---|
| 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 = DSP
|
|---|
