FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
- Recall number
- Z-0059-05
- Recalling firm
- Arrow International Inc
- Product
- Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
- Status
- Terminated
- Initiated
- 2004-09-27
- Posted
- 2004-10-28
- Terminated
- 2004-11-30
- Reason
- Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK
- Root cause
- Other
- Action
- The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.
- Quantity
- 290 kits
- Distribution
- The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.
- Lot, serial or model codes
- Lot number RF4066579
- 510(k) numbers
- ["K993691"]
- 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