FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
- Recall number
- Z-0552-05
- Recalling firm
- Arrow International Inc
- Product
- Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
- Status
- Terminated
- Initiated
- 2004-09-21
- Posted
- 2005-02-18
- Terminated
- 2005-05-04
- Reason
- Product was mislabeled for lumen configuration, flow rates, and priming volume.
- Root cause
- Other
- Action
- The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.
- Quantity
- 25 kits
- Distribution
- The products were shipped to hospitals in AZ, CA, NJ, and WV.
- Lot, serial or model codes
- Lot numbers RF4088611 and RF4088128
- 510(k) numbers
- ["K930129"]
- PMA numbers
- not on file
- Product code
- LJS
- 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