Z-1219-06

TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection)...

Name: Z-1219-06 TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection)...
Creator: Kensey Nash Corp
Published: 2006-05-24
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2006-05-24 / Terminated

FDA source

Kensey Nash Corp began a recall of TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit... on 2006-05-24. The reason FDA records is "Volume control knob not able to go up to larger diameters". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1219-06
Status: Terminated
Initiated: 2006-05-24
Posted: 2006-07-12
Terminated: 2006-07-11
Recalling firm: DSM Biomedical, Inc.
Product: TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.
Product code: NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Reason for recall: Volume control knob not able to go up to larger diameters
FDA root cause: Other
Action: A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.
Quantity in commerce: 10 kits
Distribution: Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
Product codes and lots: Lot number 47303 exp 9/30/06

Product code NFA

K042040Class IITriactiv SystemKensey Nash Corp. / cleared 2005-03-23

MDM coverage of this record lists here, newest first.

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)