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Anesthesia Support Tray recallZ-1616-2022 · Mckesson Medical-Surgical Inc. Corporate Office · initiated May 25, 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 Mckesson Medical-Surgical Inc. Corporate Office 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

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

FDA root cause category: Environmental control

What the company is doing

Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 [email protected]. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT

Recall details

Recall number
Z-1616-2022
Status
Open, Classified
Initiated by the company
May 25, 2022
Posted by the FDA
Aug 26, 2022
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
16 cases
Product code
BRY
Distribution
US Nationwide

Product description

B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116

Code information (models, lots, serial numbers)

GTIN: 04046964177538; 04046964177545

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90336).

Sources and updates

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