Z-0778-2025Class II

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK...

Name: Z-0778-2025 Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-11-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-11-21 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN... on 2024-11-21. FDA classified it as Class II and gives the reason as "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0778-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-21
Posted: 2024-12-30
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
Quantity in commerce: 2344 units
Distribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Product codes and lots: 1) REF CDS840451M, UDI/DI 10195327417574 (EA) 40195327417575 (CS), Lot Numbers: 24BLA736; 2) REF DYNJ41516M, UDI/DI 10193489202564 (EA) 40193489202565 (CS), Lot Numbers: 19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171; 3) REF DYNJ54242B, UDI/DI 10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400; 4) REF DYNJ901203C, UDI/DI 10889942572526 (EA) 40889942572527 (CS), Lot numbers: 19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734; 5) REF DYNJ901203D, UDI/DI 10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830; 6) REF DYNJ906681B, UDI/DI 10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278; 7) REF DYNJ906681C, UDI/DI 10195327173838 (EA) 40195327173839 (CS) , Lot Numbers: 22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0778-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0777-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0778-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0779-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0780-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0781-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0782-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0783-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0784-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0785-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0786-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0787-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0788-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0789-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0790-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0791-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0792-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0793-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30
Z-0794-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)