The Maplewood, Minn.–based company said in the notice — reported out of Germany — that its tape product meets all safety and efficacy criteria. However, long-term exposure of the Durapore Advanced surgical tape to continuous high-moisture clinical applications has not fully met 3M’s performance expectations.
3M said usage may cause tape bond failure, meaning the tape won’t perform as intended. It may also make the tape fibers fray, which could cause them to be accidentally ingested or aspirated.
As a result of the potential issues with the surgical tape, 3M ceased sale of the Durapore Advanced surgical tape product and urged users to ensure customers are informed of the issue and to discontinue use and dispose of the product. The company said it has notified the appropriate regulatory agency.
Correction: A previous version of this story inaccurately represented the affected product in 3M’s recent field safety notice. The safety notice only applies to 3M Durapore Advanced surgical tape (“purple tape”) and does not apply to 3M Durapore surgical tape or any other 3M medical surgical tapes.