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Medline Knee Arthroscopy Kit, convenience kit, REF… recallZ-2232-2021 · Medline Industries Inc · initiated Jul 1, 2021

Terminated

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 Inc 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 kits may contain an expired component.

FDA root cause category: Employee error

What the company is doing

Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.

Recall details

Recall number
Z-2232-2021
Status
Terminated
Initiated by the company
Jul 1, 2021
Recalling firm
Medline Industries Inc
Quantity
286 kits total for all products
Product code
OJH
Distribution
US Nationwide distribution in the states of MN, NE, and PA.

Product description

Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Code information (models, lots, serial numbers)

Lot 19WBA897, Exp. 2020-12-31, GTIN (01)10193489225143.

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 88268).

Sources and updates

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