Arrow Three-Lumen CVC
FDA device recall Z-1290-2022 · posted 2022-06-27 · Terminated
Recall details
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Reason for recall
- Gravity flow rates on the affected product lidstock are incorrect.
- Action taken
- A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 10,301 units
- Distribution
- US Nationwide distribution in the states of Florida.
- Date initiated
- 2022-05-05
- Date posted
- 2022-06-27
- Date terminated
- 2024-09-04
- Location
- Morrisville, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS (K970864) | Arrow Intl., Inc. | 1997-10-17 |