Medical Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack
MEDLINE INDUSTRIES, LP - Northfield · June 27, 2024
Reason for Recall
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Product Description
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pack Number DYNJ908429; f) MASTOPEXY-CANNOVA, Pack Number DYNJ909948
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
States Affected
NATIONWIDE
Quantity Affected
407 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3109-2024
Status: ongoing
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