Z-3069-2024Class II

CRANIOTOMY PACK, Pack Number DYNJ46552O

Name: Z-3069-2024 CRANIOTOMY PACK, Pack Number DYNJ46552O
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-06-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-06-18 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of CRANIOTOMY PACK, Pack Number DYNJ46552O on 2024-06-18. FDA classified it as Class II and gives the reason as "A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3069-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-18
Posted: 2024-09-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: CRANIOTOMY PACK, Pack Number DYNJ46552O
Product code: OJH Orthopedic Tray
Reason for recall: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: Medline Industries issued a Recall notice to its consignees on 06/18/2024 via email. The notice explained the issue, potential risk, and directed the product to be stickered to instruct the used to remove the recalled component from the kit and replace from sterile supply. Distributors or those who have transferred the product were directed to notify those to whom the product was distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 188 units
Distribution: US: TX, IL, CA
Product codes and lots: UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3069-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3069-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3070-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3071-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06
Z-3072-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code OJH

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)