FDA Medical Device Recalls (openFDA)
Arrow International Inc: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
- Recall number
- Z-1082-2015
- Recalling firm
- Arrow International Inc
- Product
- ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
- Status
- Terminated
- Initiated
- 2015-01-02
- Posted
- 2015-02-10
- Terminated
- 2016-10-25
- Reason
- Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
- Root cause
- Process control
- Action
- An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
- Quantity
- 1195
- Distribution
- Nationwide
- Lot, serial or model codes
- product number CDC-42802-P1A, lot number 23F14A0063
- 510(k) numbers
- ["K071538"]
- 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