FDA Medical Device Recalls (openFDA)
Arrow International Inc: ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
- Recall number
- Z-1194-2018
- Recalling firm
- Arrow International Inc
- Product
- ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
- Status
- Terminated
- Initiated
- 2017-12-15
- Posted
- 2018-03-14
- Terminated
- 2019-07-18
- Reason
- Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 305
- Distribution
- Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.
- Lot, serial or model codes
- Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)
- 510(k) numbers
- ["K151513"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28