FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
- Recall number
- Z-1221-06
- Recalling firm
- Kensey Nash Corp
- Product
- TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
- Status
- Terminated
- Initiated
- 2006-05-24
- Posted
- 2006-07-12
- Terminated
- 2006-07-11
- Reason
- volume control knob not able to go up to larger diameters
- 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
- 15 boxes
- Distribution
- Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
- Lot, serial or model codes
- Lot numbers: 47052 exp 11/30/06, 47645 exp 12/31/06, and 49128 exp 3/31/07
- 510(k) numbers
- ["K042040"]
- PMA numbers
- not on file
- Product code
- NFA
- Firm FEI
- 1000307073
- Firm city
- Exton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28