| Date Initiated by Firm | November 22, 2023 |
|---|
| Date Posted | September 30, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0622-2024 |
|---|
| Recall Event ID |
93520 |
| 510(K)Number | K842648 |
|---|
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 |
|---|
| Code Information |
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
|
Recalling Firm/
Manufacturer |
DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
|
| For Additional Information Contact |
865-938-7828 |
|---|
Manufacturer Reason
for Recall | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. |
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FDA Determined
Cause 2 | Device Design |
|---|
| Action | DeRoyal Industries issued am URGENT FIELD CORRECTIVE ACTION notice to its sole consignee on 11/22/2023 via email. The notice explained the issue and provided instructions on the proper use of the device. |
|---|
| Quantity in Commerce | 252 units |
|---|
| Distribution | US: Virginia |
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| 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 = LRO
|
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