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Recall Observatory FDA recall evidence

Device product

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

Z-1789-2022

May 25, 2022

Class III

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 90731
Status
Ongoing
Classification
Class III
Quantity
25
Official record key
device-enforcement:Z-1789-2022

Official wording

Reason: 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.

Code information: GTIN: 00714196391346; 01714196300019; 00714196300010

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.