ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
FDA device recall Z-1194-2018 · posted 2018-03-14 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
- Action taken
- Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 305
- Distribution
- Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
- Date initiated
- 2017-12-15
- Date posted
- 2018-03-14
- Date terminated
- 2019-07-18
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Arrow Endurance Extended Dwell Peripheral Catheter System (K151513) | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | 2015-07-08 |