Recall Z-0168-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated September 4, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
Codes / lots: UDI/DI 40888277567925 (each), 10888277567924 (case), Lot Numbers: 23LBS908
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
FDA-determined cause: Under Investigation by firm
Action taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Details
- Recall number
- Z-0168-2025
- Initiated
- September 4, 2024
- Posted by FDA
- October 23, 2024
- Product code
- LRS – I.V. Start Kit
- Quantity
- 120 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0148-2025 Class II | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0149-2025 Class II | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0150-2025 Class II | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0151-2025 Class II | Centurion OB TRAY, REF MNS13965A; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0152-2025 Class II | Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0153-2025 Class II | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0154-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0155-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0156-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C -…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0157-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0158-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0159-2025 Class II | Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0160-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0161-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0162-2025 Class II | Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0163-2025 Class II | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0164-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0165-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0166-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF…XXX | 09/04/2024Open, Classified |
| Z-0167-2025 Class II | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0169-2025 Class II | Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0170-2025 Class II | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0171-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0172-2025 Class II | Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0173-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0174-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0175-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0176-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0177-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |
| Z-0178-2025 Class II | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | 09/04/2024Open, Classified |