Coloplast Manufacturing US, LLC: Medical Device Recall in 2014 - (Recall #: Z-0138-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: September 8, 2014

Date Posted: November 5, 2014

Recall Number: Z-0138-2015

Event ID: 69279

Reason for Recall:

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

Status: Terminated

Product Quantity: 6

Code Information:

4201931

Distribution Pattern:

US Distribution to MO and RI.

Voluntary or Mandated:

Voluntary: Firm initiated