Z-1221-06

TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes

Name: Z-1221-06 TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes
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 Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes 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-1221-06
Status: Terminated
Initiated: 2006-05-24
Posted: 2006-07-12
Terminated: 2006-07-11
Recalling firm: DSM Biomedical, Inc.
Product: TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
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: 15 boxes
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 numbers: 47052 exp 11/30/06, 47645 exp 12/31/06, and 49128 exp 3/31/07

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)