FDA Medical Device Recalls (openFDA)
Impact Instrumentation, Inc.: Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
- Recall number
- Z-2430-2012
- Recalling firm
- Impact Instrumentation, Inc.
- Product
- Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
- Status
- Terminated
- Initiated
- 2012-03-30
- Posted
- 2012-09-20
- Terminated
- 2015-07-21
- Reason
- A shipment mix-up took place.
- Root cause
- Process control
- Action
- The firm, Impact Instrumentation Inc., contacted their customers via phone and email notification on April 9, 2012. Customers were provided the correct packing slip and asked to acknowledge the correction. If you have any questions, contact the Regulatory Affairs Manager at 973-882-1212 or email: aglordano@impactii.com.
- Quantity
- 2 devices
- Distribution
- Nationwide distribution: USA including states of: FL and OH.
- Lot, serial or model codes
- Model 324JL S/N 120142 and S/N 120144
- 510(k) numbers
- ["K820331"]
- PMA numbers
- not on file
- Product code
- JCX
- 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