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Surgical convenience kits labeled as recallZ-1120-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 7, 2022

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

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "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. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."

Recall details

Recall number
Z-1120-2023
Status
Open, Classified
Initiated by the company
Dec 7, 2022
Posted by the FDA
Feb 10, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
981 units
Product code
MCY
Distribution
Nationwide

Product description

Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

Code information (models, lots, serial numbers)

a) Reorder number DYNDC2733, GTIN 40888277783974, Lot # 22HMG957; b) Reorder number SUT14640, GTIN 40653160184158, Lot # 22HMG490

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 91483).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page