Z-2209-2020Class II

EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

Name: Z-2209-2020 EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Creator: Bard Peripheral Vascular Inc
Published: 2019-06-14
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-06-14 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F on 2019-06-14. FDA classified it as Class II and gives the reason as "Incorrect Peel-Apart Introducer Sheath in Kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2209-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Posted: 2020-06-03
Terminated: 2024-09-18
Recalling firm: Bard Peripheral Vascular Inc
Product: EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Incorrect Peel-Apart Introducer Sheath in Kit.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification.
Quantity in commerce: 400
Distribution: 67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Product codes and lots: RECT0999

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2208-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2209-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code MSD

K090901Class IIEsensor Cf Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models Xt-8Osmetech Molecular Diagnostics / cleared 2009-07-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)