FDA Medical Device Recalls (openFDA)
Impact Instrumentation, Inc.: Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
- Recall number
- Z-0870-2012
- Recalling firm
- Impact Instrumentation, Inc.
- Product
- Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
- Status
- Terminated
- Initiated
- 2011-11-04
- Posted
- not on file
- Terminated
- 2013-05-23
- Reason
- A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.
- Root cause
- Component design/selection
- Action
- Impact Instrumentation Inc. sent an URGENT Device Product Recall letter dated November 3, 2011 to all affected consignees. The letter identified the product, problem, instructions for product returns, and actions to be taken. The letter states that Impact will arrange for expedited return, at no charge to the customers of the affected units. The notice instructs customers to complete and return the Recall Tracking Form. If you need additional information, please call Impact Customer Service at (800) 969-0750
- Quantity
- 57 units
- Distribution
- Worldwide Distribution - USA (nationwide)
- Lot, serial or model codes
- K051476
- 510(k) numbers
- ["K051476"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 1220908
- Firm city
- West Caldwell
- Firm state
- NJ
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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