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Terminated

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

FDA Recall Z-1221-06 · Posted 2006-07-12

Recalling FirmKensey Nash Corp
Recall StatusTerminated
Product CodeNFA
Date Initiated2006-05-24
Date Terminated2006-07-11
Product Quantity15 boxes

Reason for Recall

volume control knob not able to go up to larger diameters

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042040TRIACTIV SYSTEMKensey Nash Corp. · 2005-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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