Z-0100-2022Class II

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

Name: Z-0100-2022 smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Creator: Smiths Medical ASD Inc.
Published: 2020-03-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-03-10 / Terminated / root cause: design

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 on 2020-03-10. FDA classified it as Class II and gives the reason as "Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0100-2022
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Posted: 2021-10-13
Terminated: 2023-09-22
Recalling firm: Abbott Medical
Product: smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Product code: DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Reason for recall: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products.
Quantity in commerce: 20800 units
Distribution: Austria, France, Germany, Great Britain, and Saudi Arabia
Product codes and lots: All codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0092-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0093-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0094-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0095-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0096-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0097-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0098-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0099-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0100-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0101-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0102-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13
Z-0103-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-13

Product code DRO

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)