FDA Medical Device Recalls (openFDA)
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company: Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Recall number
- Z-0490-2019
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Product
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Status
- Terminated
- Initiated
- 2017-09-05
- Posted
- not on file
- Terminated
- 2024-09-23
- Reason
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Root cause
- Other
- Action
- Firm sent recall notification letters to customers on 9/5/2017.
- Quantity
- 10,440
- Distribution
- AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI
- Lot, serial or model codes
- Model # FB-A-400-107 Lot Number: 4J006
- 510(k) numbers
- ["K080779"]
- PMA numbers
- not on file
- Product code
- FQH
- Firm FEI
- 1417519
- Firm city
- Vernon Hills
- Firm state
- IL
- 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