Z-1578-2023Class II

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Name: Z-1578-2023 COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Creator: Merit Medical Systems, Inc.
Published: 2023-03-21
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2023-03-21 / Open, Classified

FDA source

Merit Medical Systems, Inc. began a recall of COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units on 2023-03-21. FDA classified it as Class II and gives the reason as "Custom sheath Introducer contains incorrect needle size". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1578-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-21
Posted: 2023-05-10
Recalling firm: Merit Medical Systems, Inc.
Product: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Product code: DYB Introducer, Catheter
Reason for recall: Custom sheath Introducer contains incorrect needle size
FDA root cause: Unknown/Undetermined by firm
Action: On March 21, 2023 MeritMedical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. In addition to informing them about the recall, MeritMedical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. If you have any questions concerning this communication, please don t hesitate to contact your Merit OEM Sales Representative or Merit OEM Customer Service at (800)-637-4839| Hours: 8 am to 5 pm MST | Mon-Fri.
Quantity in commerce: 1186 units
Distribution: US Distribution to state of: Minnesota
Product codes and lots: Lot # H2122096S1; UDI-DI: (00)884450525197

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1578-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1578-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code DYB

K070159Class IIPrelude Sheath IntroducerMerit Medical Systems, Inc. / cleared 2007-06-21

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)