| Date Initiated by Firm | November 09, 2021 |
|---|
| Create Date | April 07, 2022 |
|---|
| Recall Status1 |
Terminated 3 on August 07, 2024 |
| Recall Number | Z-0895-2022 |
|---|
| Recall Event ID |
89714 |
| 510(K)Number | K212026 |
|---|
| Product Classification |
Catheter, percutaneous - Product Code DQY
|
| Product | Amplatzer Steerable Delivery Sheath |
|---|
| Code Information |
Model ASDS-14F-075, Batch Numbers:
1) 7963817
2) 7976534
3) 7981029
4) 7990340
5) 8008111
6) 8010056
7) 8025120
8) 8102214
9) 8106240
10) 8234848
11) 8274323
12) 8277741
|
Recalling Firm/
Manufacturer |
Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
|
| For Additional Information Contact | Cynthia Kong
408-845-0883 |
|---|
Manufacturer Reason
for Recall | Instructions for use were updated. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible.
The product is not being removed from the field and does not need to be returned.
The recalling firm is providing additional instructions to reduce the potential for air ingress. |
|---|
| Quantity in Commerce | 529 units |
|---|
| Distribution | OUS distribution only |
|---|
| 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 = DQY
|
|---|
