Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesi

FDA device recall Z-0138-2015 · posted 2014-10-24 · Terminated

Recall details

Recalling firm

Coloplast Manufacturing US, LLC

Reason for recall

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

Action taken

Coloplast sent an "Urgent Voluntary Recall Notification" dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If they have further distributed the product they need to contact their customers immediately. For questions they can contact Coloplast Customer Care Representative at 800-533-0464. A second follow up "Urgent Voluntary Recall Notification" letter dated September 23, 2014 was also sent to consignees.

Root cause

Labeling mix-ups

Status

Terminated

Product code

NAD

Quantity affected

6

Distribution

US Distribution to MO and RI.

Date initiated

2014-09-08

Date posted

2014-10-24

Date terminated

2015-01-21

Location

Minneapolis, MN