Recalls / —
—#35143
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
- FDA product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K930129
- Affected lot / code info
- Lot numbers RF4088611 and RF4088128
Why it was recalled
Product was mislabeled for lumen configuration, flow rates, and priming volume.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- The products were shipped to hospitals in AZ, CA, NJ, and WV.
Timeline
- Recall initiated
- 2004-09-21
- Posted by FDA
- 2005-02-18
- Terminated
- 2005-05-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #35143. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.