Z-0552-05

Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger...

Name: Z-0552-05 Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger...
Creator: Arrow International Inc
Published: 2004-09-21
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2004-09-21 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire... on 2004-09-21. The reason FDA records is "Product was mislabeled for lumen configuration, flow rates, and priming volume". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0552-05
Status: Terminated
Initiated: 2004-09-21
Posted: 2005-02-18
Terminated: 2005-05-04
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Product was mislabeled for lumen configuration, flow rates, and priming volume.
Root cause tag: labeling and UDI
FDA 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 in commerce: 25 kits
Distribution: The products were shipped to hospitals in AZ, CA, NJ, and WV.
Product codes and lots: Lot numbers RF4088611 and RF4088128

Product code LJS

K930129Class IIArrow Picc-Peripherally Inserted Central CatheterArrow Intl., Inc. / cleared 1994-03-28

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)