Recall archive / FDA device enforcement
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; ... — FDA record Z-0778-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 2344 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0778-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 8, 2025
- Recall initiation date
- Nov 21, 2024
- Center classification date
- Dec 30, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.