Medline Industries, LP: 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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI. Quantity: 24388 units Lot/code info: Medline Kit Number/SKU DYNJ47625B, UDI/DI 10889942182589 (each), 40889942182580 (case), Lot Number 21LBI584; Medline Kit Number/SKU DYNJ912219, UDI/DI 10198459676048 (each), 40198459676049 (case), Lot Number 26BBQ085; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 23BBK437; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22LBP927; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22KBA970; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22JBH943; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22HBR879; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 25ABD038; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24IBP599; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24HBT938; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24GBB724; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24DBK110; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24ABN322; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 4019532740888

UPC codes

10889942182589, 40889942182580, 10198459676048, 40198459676049, 10195327205980, 40195327205981, 10195327408886, 40195327408887, 10193489352504, 40193489352505, 10195327446635, 40195327446636, 10195327191092, 40195327191093, 10198459495823, 40198459495824, 10198459572753, 40198459572754, 10195327350635, 40195327350636, 10195327637651, 40195327637652, 10198459485565, 40198459485566, 10193489555820, 40193489555821, 10195327188221, 40195327188222, 10889942572595, 40889942572596

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.