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
This recall is currently active, issued September 11, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 27, 2024
- Posted
- September 11, 2024
- Recall Number
- Z-3109-2024
- Quantity
- 407 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot / Code Info
a) DYKE1456D: UDI/DI case 40195327639939, UDI/DI each 10195327639938, Lot Numbers: 24CBK289, 24BBK989; b) DYNJ908099B: UDI/DI case 40195327507085, UDI/DI each 10195327507084, Lot Numbers: 24DBI371, 24BBA188; c) DYNJ908101B: UDI/DI case 40195327507092, UDI/DI each 10195327507091, Lot Numbers: 24CBE408, 24BBA260, 24ABB112; d) DYNJ908105B: UDI/DI case 40195327507122, UDI/DI each 10195327507121, Lot Numbers: 24ABV362; e) DYNJ908429: UDI/DI case 40195327078820, UDI/DI each 10195327078829, Lot Numbers: 24CBB310, 23LBV007; f) DYNJ909948: UDI/DI case 40195327512911, UDI/DI each 10195327512910, Lot Numbers: 24DBD609
Root Cause
Process control
Action Taken
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 recalls@medline.com.