—#210179

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;

FDA product code: OFF — Central Venous Catheter Tray
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Timeline

Recall initiated: 2024-09-04
Posted by FDA: 2024-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.