Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRONCH LAB PACK-LF, Pack Number DYNJ24810B; f) THORACIC, Pack Number DYNJ907991F; g) RECTAL, Pack Number DYNJ908108A; h) ROBOTIC, Pack Number DYNJ908109C; i) CERVICAL, Pack Number DYNJ908748D; j) LAMI, Pack Number DYNJ908750D; k) MERCY TIFFIN BASIC-LF, Pack Number DYNJ909731; l) MERCY TIFFIN LITHOTOMY, Pack Number DYNJ909735; m) BASIC GENERAL SET UP, Pack Number DYNJ909945; n) BASIC GENERAL SET UP, Pack Number DYNJ909945A; o) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289; p) AMB OCULOPLASTICS MUSC, Pack Number DYNJ910289H; q) MTHZ TOTAL HIP, Pack Number DYNJC9311M; r) BRONCH KIT, Pack Number P906877

FDA Recall Z-3114-2024 · Posted 2024-09-11

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2024-06-27
Product Quantity3117 units

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.

Firm Action

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or [email protected].

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑