Kensey Nash Corp ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.
Brand
Kensey Nash Corp
Lot Codes / Batch Numbers
Catalog number 61030-01, Lot number 56662 exp 2/28/08
Products Sold
Catalog number 61030-01, Lot number 56662 exp 2/28/08
Kensey Nash Corp is recalling ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 p due to Insufficient wire sealing. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Insufficient wire sealing
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026