Recall Z-0157-2025
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 brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PACK-LF, REF DYNJ28487; g) PICC PACK-LF, REF DYNJ28487H; h) CENTRAL LINE PACK, REF DYNJ30087C; i) CENTRAL LINE ADULT PACK, REF DYNJ35352; j) PICC PACK, REF DYNJ52255; k) PICC PROCEDURE PACK, REF DYNJ59067A; l) PICC PROCEDURE PACK, REF DYNJ59067A; m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A; n) PICC TEAM PACK, REF DYNJ64542A; o) PICC LINE INSERTION PACK, REF DYNJ65519; p) CVL INSERTION KIT II PGYBK, REF DYNJ68112; q) CVL INSERTION KIT II PGYBK, REF DYNJ68112; r) PICC PACK, REF DYNJ69088A; s) PICC INSERTION TRAY, REF DYNJ80031; t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A; u) CVR ENDOVENOUS PACK, REF DYNJ80643; v) RADIAL ARTERY PACK, REF DYNJ83938;
Codes / lots: a) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 24ABK903; b) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 23LBN351; c) REF DYNJ20803D, UDI/DI 40889942553885 (each), 10889942553884 (case), Lot Numbers: 24ABE939; d) REF DYNJ28368, UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 24ABD995; e) REF DYNJ28368, UDI/DI UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 23KBE939; f) REF DYNJ28487, UDI/DI 40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626; g) REF DYNJ28487H, UDI/DI40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626; h) REF DYNJ30087C, UDI/DI 40889942754145 (each), 10889942754144 (case), Lot Numbers: 23JBS113; i) REF DYNJ35352, UDI/DI 40884389433080 (each), 10884389433089 (case), Lot Numbers: 23LBN154; j) REF DYNJ52255, UDI/DI 40889942253709 (each), 10889942253708 (case), Lot Numbers: 24ABC063; k) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 24ABC903; l) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 23LBM072; m) REF DYNJ61247A, UDI/DI 40195327492862 (each)…
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-0157-2025
- Initiated
- September 4, 2024
- Posted by FDA
- October 23, 2024
- Product code
- OFF – Central Venous Catheter Tray
- Quantity
- 5238 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-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-0168-2025 Class II | Medline IV TEAM PICC, REF DYNJ48222; 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 |