Z-0835-2007

ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box

Name: Z-0835-2007 ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box
Creator: Kensey Nash Corp
Published: 2007-03-28
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2007-03-28 / Terminated

FDA source

Kensey Nash Corp began a recall of ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box on 2007-03-28. The reason FDA records is "Insufficient wire sealing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0835-2007
Status: Terminated
Initiated: 2007-03-28
Posted: 2007-05-31
Terminated: 2007-08-30
Recalling firm: DSM Biomedical, Inc.
Product: ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Insufficient wire sealing
FDA root cause: Other
Action: On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.
Quantity in commerce: 11 units
Distribution: Worldwide, including USA and Germany.
Product codes and lots: Catalog number 61030-01, Lot number 56662 exp 2/28/08

Product code FRO

K061772Class IITriactiv Fx Embolic Protection SystemKensey Nash Corp. / cleared 2006-07-11

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)