Z-0783-2021Class II

Cardiac Pack - LF, Model DYNJ31903I -

Name: Z-0783-2021 Cardiac Pack - LF, Model DYNJ31903I -
Creator: Medline Industries Inc
Published: 2020-11-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-11-13 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck... on 2020-11-13. FDA classified it as Class II and gives the reason as "The cylindrical sponge component is not x-ray detectable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0783-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-13
Posted: 2021-01-07
Terminated: 2021-10-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: The cylindrical sponge component is not x-ray detectable.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.
Quantity in commerce: 360
Distribution: Foreign distribution only - Canada.
Product codes and lots: Lot 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0783-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0779-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0780-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0781-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0782-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0783-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07

Product code OEZ

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)