FDAFDA · Food and drugs·Recall number Z-0157-2025
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;
Published October 30, 2024 · Recall initiated: September 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot
- 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), 10195327492861 (case), Lot Numbers: 23LBN198; n) REF DYNJ64542A, UDI/DI 40193489293723 (each), 0193489293722 (case), Lot Numbers: 23LBN027; o) REF DYNJ65519, UDI/DI 40193489283939 (each), 10193489283938 (case), Lot Numbers: 24ABE345; p) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 24ABH428; q) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 23LBT018; r) REF DYNJ69088A, UDI/DI 40193489975247 (each), 10193489975246 (case), Lot Numbers: 23LBP745; s) REF DYNJ80031, UDI/DI 40195327007745 (each), 10195327007744 (case), Lot Numbers: 23LBN003; t) REF DYNJ80489A, UDI/DI 40195327582723 (each), 10195327582722 (case), Lot Numbers: 23LBP033; u) REF DYNJ80643, UDI/DI 40195327055791 (each), 10195327055790 (case), Lot Numbers: 23KBK131; v) REF DYNJ83938, UDI/DI 40195327317233 (each), 101953273172329 (case), Lot Numbers: 24ABG864
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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