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Medline procedure kits labeled as recallZ-1040-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 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

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.

Recall details

Recall number
Z-1040-2025
Status
Open, Classified
Initiated by the company
Nov 18, 2024
Posted by the FDA
Jan 28, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
749 units
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution.

Product description

Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray

Code information (models, lots, serial numbers)

1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case), Lot Numbers: 2024040490, 2024073190, 2024082790, 2024101790,; 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case), Lot Numbers: 2024050990.

Devices named in this recall

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

Other devices under the same FDA submission

319 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96110).

Sources and updates

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