Z-3048-2026Class II

Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A...

Name: Z-3048-2026 Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A...
Creator: Medline Industries, LP
Published: 2026-06-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A on 2026-06-12. The reason FDA records is "The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the...". 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-3048-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-12
Posted: 2026-08-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 6/12/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 104 kits
Distribution: US Nationwide distribution.
Product codes and lots: 1) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3048-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3048-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3049-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3050-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3051-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3052-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3053-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3054-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3055-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3056-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3057-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3058-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3059-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3060-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3061-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3062-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3063-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31

Product code CAI

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)