FDA Medical Device Recalls (openFDA)
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company: Portex Unit Dose 15 ml Normal Saline
- Recall number
- Z-0720-2019
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Product
- Portex Unit Dose 15 ml Normal Saline
- Status
- Terminated
- Initiated
- 2017-09-05
- Posted
- 2019-02-04
- Terminated
- 2024-04-16
- Reason
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Root cause
- Process control
- Action
- Firm sent recall notification letters to customers on 9/5/2017.
- Quantity
- 357,552
- Distribution
- Worldwide distribution: US (nationwide) to states of: 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, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
- Lot, serial or model codes
- Model # R0159 Lot Numbers: ¿A661, B067, A526, A536, A569, and B201
- 510(k) numbers
- ["K820227"]
- PMA numbers
- not on file
- Product code
- CAF
- 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