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DermaCol 100 recallZ-1789-2022 · 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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

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-1789-2022
Status
Open, Classified
Initiated by the company
May 25, 2022
Posted by the FDA
Sep 26, 2022
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
25
Product code
KGN
FDA submissions
K171645
Distribution
US Nationwide distribution.

Product description

DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E

Code information (models, lots, serial numbers)

GTIN: 00714196391346; 01714196300019; 00714196300010

Devices named in this recall

2 devices 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 90731).

Sources and updates

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