Z-2489-2018Class II

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221...

Name: Z-2489-2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221...
Creator: Cardinal Health 200, LLC
Published: 2018-06-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-06-11 / Terminated / root cause: design

FDA source

Cardinal Health 200, LLC began a recall of Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX... on 2018-06-11. FDA classified it as Class II and gives the reason as "The suction valve may not close properly which could cause continuous suction". 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-2489-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-07-18
Terminated: 2020-08-17
Recalling firm: Medtronic, Inc.
Product: Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Product code: GBX Catheter, Irrigation
Reason for recall: The suction valve may not close properly which could cause continuous suction.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.
Quantity in commerce: A total of 63,020 valves were distributed. Specific product quantities were not provided.
Distribution: Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.
Product codes and lots: Lot numbers 11740,41771,41772,41773, and 81709.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2489-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2486-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2487-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2488-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2489-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2490-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2491-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2492-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2493-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2494-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18
Z-2495-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18

Product code GBX

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)