Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number
Summary
The FDA issued a Class II for Medline convenience kits containing semi-rigid suction liners labeled as follows by MEDLINE INDUSTRIES, LP - Northfield. Reason: 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 0.
Details
Source
Device Recall
External ID
Z-3106-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
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
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
Quantity Affected: 29,585 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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-27
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3106-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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