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KIT PEDI CRANI LAMI, Pack Number DYNJ907372A recallZ-3070-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jun 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

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].

Recall details

Recall number
Z-3070-2024
Status
Open, Classified
Initiated by the company
Jun 18, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
485 units
Product code
OJH
Distribution
US: TX, IL, CA

Product description

KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

Code information (models, lots, serial numbers)

UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95127).

Sources and updates

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