MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SK

Medline Industries, LP

The hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model Medline Kit Number/SKU DYNJ47625BModel UDI/DI 10889942182589 (each)Model 40889942182580 (case)Model Lot Number 21LBI584Model Medline Kit Number/SKU DYNJ912219Model UDI/DI 10198459676048 (each)Model 40198459676049 (case)Model Lot Number 26BBQ085Model Medline Kit Number/SKU DYNJ907033BModel UDI/DI 10195327205980 (each)Model 40195327205981 (case)Model Lot Number 23BBK437Model Lot Number 22LBP927Model Lot Number 22KBA970Model Lot Number 22JBH943UPC 10889942182589UPC 40889942182580UPC 10198459676048UPC 40198459676049UPC 10195327205980UPC 40195327205981UPC 10195327408886UPC 40195327408887

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.