| Date Initiated by Firm | April 09, 2024 |
|---|
| Date Posted | May 13, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1810-2024 |
|---|
| Recall Event ID |
94451 |
| 510(K)Number | K230041 |
|---|
| Product Classification |
Pump, infusion - Product Code FRN
|
| Product | Spectrum IQ Infusion pump, Product Code 357009 |
|---|
| Code Information |
UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419 |
Recalling Firm/
Manufacturer |
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
|
| For Additional Information Contact | Center for One Baxter
800-422-9837 |
|---|
Manufacturer Reason
for Recall | There is a potential for cracks on the mount of the front panel of the device. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone. |
|---|
| Quantity in Commerce | 9 units |
|---|
| Distribution | US Nationwide distribution in the states of Ohio, Wisconsin. |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = FRN
|
|---|
