Z-0349-05

NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in...

Name: Z-0349-05 NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in...
Creator: Arrow International Inc
Published: 2004-11-24
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2004-11-24 / Terminated

FDA source

Arrow International Inc began a recall of NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S... on 2004-11-24. The reason FDA records is "complaints of vessel erosion when using this product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0349-05
Status: Terminated
Initiated: 2004-11-24
Posted: 2005-01-08
Terminated: 2006-06-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: complaints of vessel erosion when using this product
FDA root cause: Other
Action: The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory.
Quantity in commerce: 36340 units
Distribution: The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sold in Taiwan, Brazil, Hong Kong, Africia, and Canada.
Product codes and lots: All lots higher than number 3231

Product code LJS

K970434Class IINeo-PiccKlein-Baker Medical, Inc. / cleared 1997-04-01

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)