Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pac... — FDA record Z-3029-2024
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 Apr 8, 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 Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1638; 10) BIOPSY PACK, Pack Number DYNDH1699; 11) LACERATION TRAY, Pack Number DYNDL1159B; 12) SUTURE TRAY, Pack Number DYNDS1064B; 13) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 15) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 16) ARTHROGRAM PACK, Pack Number P241108; 17) PACK BONE MARROW BIOPSY, Pack Number P268481; 18) BIOPSY BASIC PACK, Pack Number P784604; 19) ARTHROGRAM TRAY-LF, Pack Number SPEC0061B; 20) BIOPSY TRAY, Pack Number SPEC0095; 21) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 22) BONE MARROW TRAY, Pack Number SPEC0255; 23) ARTHROGRAM TRAY-LF, Pack Number SPEC0400
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3029-2024
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 | DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450; DYNDH1574, Lot Number 2022011450; DYNDH1596, Lot Number 2020122250; DYNDH1596, Lot Number 2022092090; DYNDH1638, Lot Number 2021062150; DYNDH1638, Lot Number 2021092350; DYNDH1638, Lot Number 2022011450; DYNDH1638, Lot Number 2022060750; DYNDH1699, Lot Number 2022060750; DYNDL1159B, Lot Number 2019022580; DYNDS1064B, Lot Number 2019062480; DYNDS1064B, Lot Number 2019120980; DYNJTS0214, Lot Number 2020113050; DYNJTS0214, Lot Number 2021012850; DYNJTS0214, Lot Number 2021050750; DYNJTS0214, Lot Number 2021082650; DYNJTS0214, Lot Number 2021102550; DYNJTS0214, Lot Number 2021111290; DYNJTS0214, Lot Number 2022040790; DYNJTS0214, Lot Number 2022052690; DYNJTS0214, Lot Number 2022080390; DYNJTS0214, Lot Number 2022092090; DYNJTS0214, Lot Number 2022102190; DYNJTS0214, Lot Number 2023100990; DYNJTS0214, Lot Number 2024010890; DYNJTS4306, Lot Number 2022011450; IVS3320, Lot Number 2021111290; P241108, Lot Number 2021012850; P268481, Lot Number 2022060750; P784604, Lot Number 2019120980; SPEC0061B, Lot Number 2021062150; SPEC0095, Lot Number 2020113050; SPEC0095, Lot Number 2022060750; SPEC0149, Lot Number 2020113050; SPEC0255, Lot Number 2019022580; SPEC0255, Lot Number 2019032580; SPEC0255, Lot Number 2019062480; SPEC0255, Lot Number 2019120980; SPEC0255, Lot Number 2019121080; SPEC0255, Lot Number 2020012080; SPEC0400, Lot Number 2020113050 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Sep 6, 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.