Z-1050-05

PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible...

Name: Z-1050-05 PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible...
Creator: Boston Scientific Corporation
Published: 2004-03-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-03-05 / Terminated

FDA source

Boston Scientific Corporation began a recall of PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at... on 2004-03-05. The reason FDA records is "Lumens may have incorrect lumen size marked on them". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1050-05
Status: Terminated
Initiated: 2004-03-05
Posted: 2005-07-28
Terminated: 2006-02-06
Recalling firm: Boston Scientific Corporation
Product: PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Lumens may have incorrect lumen size marked on them.
FDA root cause: Other
Action: Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
Quantity in commerce: 45 units
Distribution: Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
Product codes and lots: 919488, 924206

Product code LJS

K963097Class IIClampless Valved Catheter-Picc (Cvc-Picc)Bmw Medical, Inc. / cleared 1996-10-18

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)