| Date Initiated by Firm | November 16, 2021 |
|---|
| Create Date | December 27, 2021 |
|---|
| Recall Status1 |
Terminated 3 on June 18, 2024 |
| Recall Number | Z-0420-2022 |
|---|
| Recall Event ID |
89123 |
| Product Classification |
Introducer, catheter - Product Code DYB
|
| Product | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM |
|---|
| Code Information |
Model 407831, Lot 7748246, GTIN: 15414734008805 |
| FEI Number |
3005334138
|
Recalling Firm/
Manufacturer |
Abbott
5050 Nathan Ln N
Plymouth MN 55442-3209
|
| For Additional Information Contact | Alicia Swanson
408-845-3427 |
|---|
Manufacturer Reason
for Recall | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was
manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in
length instead of the intended 5 cm in length. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices. |
|---|
| Quantity in Commerce | 10 units |
|---|
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia. |
|---|
| 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.
|
