PlainRecalls
FDA Devices Low Class III Terminated

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasio

Reported: November 5, 2014 Initiated: September 8, 2014 #Z-0138-2015

Product Description

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

Reason for Recall

Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.

Details

Units Affected
6
Distribution
US Distribution to MO and RI.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 6.
Why was this product recalled? ▼
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Low. Recall number: Z-0138-2015.

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