Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pack Number DYNJAA10579; e) BREATHING CIRCUIT # 34827, Pack Number DYNJAAF6674I
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-3106-2024
- Quantity
- 29,585 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) DYNJAA0311C: UDI/DI case: 40193489343510, UDI/DI each 10193489343519, Lot Numbers: 24DBV950, 24CBL800, 24BBI902, 23LBT319; b) DYNJAA0323C: UDI/DI case 40195327423699, UDI/DI each 10195327423698, Lot Numbers: 24DBM735, 24DBN216, 24CBI422, 24CBJ132, 23KBU156; c) DYNJAA0378A: UDI/DI case 40195327450046, UDI/DI each 10195327450045, Lot Numbers: 24DBQ840, 24DBQ839, 24DBB513, 24ABM732, 24ABU331, 24ABU330, 24ABQ036, 24ABK802, 24ABF565, 24ABG771, 23LBN692, 23LBL609, 23KBU727; d) DYNJAA10579: UDI/DI casev40889942600749, UDI/DI unit 10889942600748, Lot Numbers: 23LBL288; e) DYNJAAF6674I: UDI/DI case 40195327381623, UDI/DI each 10195327381622, Lot Numbers: 24DBM458, 24CBS798, 24CBO294, 23LBV673
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.