Z-1112-05

PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous...

Name: Z-1112-05 PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous...
Creator: Boston Scientific Corporation
Published: 2004-05-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-05-25 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a... on 2004-05-25. The reason FDA records is "Kits labeled to contain 0.028" guidewire contain 0.038" guidewire". 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-1112-05
Status: Terminated
Initiated: 2004-05-25
Posted: 2005-08-10
Terminated: 2006-02-06
Recalling firm: Boston Scientific Corporation
Product: PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.
Quantity in commerce: 290
Distribution: 278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.
Product codes and lots: 934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.

Product code LJS

K963806Class IIClampless Valved Catheter - Tunneled (Cvc-T)Bmw Medical, Inc. / cleared 1996-12-12

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)