Z-0749-2021Class II

Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For...

Name: Z-0749-2021 Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For...
Creator: Merit Medical Systems, Inc.
Published: 2020-11-10
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2020-11-10 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include... on 2020-11-10. FDA classified it as Class II and gives the reason as "Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0749-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Posted: 2020-12-29
Terminated: 2022-10-05
Recalling firm: Merit Medical Systems, Inc.
Product: Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On November 10, 2020, Merit Medical sent a "Urgent Product Recall Notice to affected consignees via FedEx mail In addition, to informing consignees about the recall issue, the firm ask 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 10 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 dont hesitate to contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.
Quantity in commerce: 90 kits
Distribution: US distribution to: KY, RI, and MD
Product codes and lots: (01)00884450255803 Lot # T1883210

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0749-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0749-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0750-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0751-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29

Product code OEQ

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