Z-3112-2024Class II

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number...

Name: Z-3112-2024 Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-06-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-06-27 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B on 2024-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3112-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-27
Posted: 2024-09-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Product code: PPB Foley Catheter Kit (Excludes Hiv Testing)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 1616 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product codes and lots: a) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B: UDI/DI case 40193489797832, UDI.DI each 10193489797831; Lot Numbers: 24CBR722, 24FBA408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3112-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3105-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3106-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3107-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3108-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3109-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3110-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3111-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3112-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3113-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3114-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3115-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3116-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3117-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3118-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3119-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3120-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3121-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11

Product code PPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)