Medline Industries, LP: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

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: 123030 units Lot/code info: Medline Kit Number/SKU BIOB686: UDI/DI 10193489684025 (each), 40193489684026 (case), Lot Number 22CMD618; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23BBK690; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABK356; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 23ABG037; Medline Kit Number/SKU DYNJ83242: UDI/DI 10195327242398 (each), 40195327242399 (case), Lot Number 22IBL708; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBK706; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24GBH415; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBQ282; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 24FBC513; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23KBK097; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23DBF286; Medline Kit Number/SKU DYNJ83242A: UDI/DI 10195327350727 (each), 40195327350728 (case), Lot Number 23CBI425; Medline Kit Number/SKU DYNJ83242C: UDI/DI 10198459575655 (each), 40198459575656 (case), Lot Number 26DBE336; Medline Kit Number/SKU DYNJ67486A: UDI/DI 10193489888768 (each), 40193489888769 (case), Lo

UPC codes

10193489684025, 40193489684026, 10195327242398, 40195327242399, 10195327350727, 40195327350728, 10198459575655, 40198459575656, 10193489888768, 40193489888769, 10888277538689, 40888277538680, 10195327659646, 40195327659647, 10884389650059, 40884389650050, 10195327557324, 40195327557325, 10195327659691, 40195327659692, 10889942029075, 40889942029076, 10198459438240, 40198459438241, 10198459289392, 40198459289393, 10198459289439, 40198459289430, 10193489206067, 40193489206068, 10193489754353, 40193489754354, 10195327584054, 40195327584055, 10195327668471, 40195327668472, 10198459425394, 40198459425395, 10198459676673, 40198459676674

Source

Official record: FDA (Device enforcement) ↗

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