CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report
Medline custom medical procedure kits labeled as recalled
Medline Industries LP - Northfield is recalling Medline custom medical procedure kits labeled as: Open Heart Cds-lf; Neuro Pack, distributed nationwide in the US. The recall was initiated on 21 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0778-2025
- FDA event ID
- 95852
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2024
- FDA classified
- 30 Dec 2024
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Nov 2024 | Recall initiated by company | |
| 30 Dec 2024 | Classified by FDA | +39 days |
| 8 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Questions about this recall
Why was it recalled?
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 95852More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |