Z-0718-2019Class I

Medline Prefilled 350 ml Sterile

Name: Z-0718-2019 Medline Prefilled 350 ml Sterile
Creator: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Published: 2017-09-05
License: https://open.fda.gov/license/

Amsino Healthcare (USA) Inc. / initiated 2017-09-05 / Terminated / root cause: manufacturing process

FDA source

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company began a recall of Medline Prefilled 350 ml Sterile on 2017-09-05. FDA classified it as Class I and gives the reason as "Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0718-2019
Classification: Class I
Status: Terminated
Initiated: 2017-09-05
Posted: 2019-02-04
Terminated: 2024-04-16
Recalling firm: Amsino Healthcare (USA) Inc.
Product: Medline Prefilled 350 ml Sterile
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm sent recall notification letters to customers on 9/5/2017.
Quantity in commerce: 235,560
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.
Product codes and lots: Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0718-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0710-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0711-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0712-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0713-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0714-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0715-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0716-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0717-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0718-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0719-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0720-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0721-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0722-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04

Product code CAF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)