Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130
FDA device recall Z-0552-05 · posted 2005-02-18 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Product was mislabeled for lumen configuration, flow rates, and priming volume.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 25 kits
- Distribution
- The products were shipped to hospitals in AZ, CA, NJ, and WV.
- Date initiated
- 2004-09-21
- Date posted
- 2005-02-18
- Date terminated
- 2005-05-04
- 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 PICC-PERIPHERALLY INSERTED CENTRAL CATHETER (K930129) | Arrow Intl., Inc. | 1994-03-28 |