The Recall Desk
HighFDA (Devices)·Z-2590-2016·Announced 2016-08-24

Avid Medical Recalls MOHS Procedure Kits with Unlabeled Latex Dressing

Avid Medical is recalling 240 MOHS procedure kits that included a latex-containing dressing without proper labeling.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (latex) mislabeling on a medical device, which fits the rubric criteria for a High severity score (3) as it presents a risk of harm without reported fatalities or FDA Class I classification.

Plain-English summary

Avid Medical, Inc. is recalling 240 units of Convenience Kits, MOHS "OPENING" PROCEDURE TRAY. The recall is due to a labeling error where a latex-containing Telfa Non-adherent Dressing (4"x3") was included in the kits without the packaging indicating the presence of latex.

The affected product is identified by Catalog No. MCVA0089-04 and LOT# 1027144. The recalled kits were distributed to two states: Virginia and Massachusetts.

This recall is classified as Class II by the FDA. Individuals with a known latex allergy should avoid using these kits. Healthcare facilities and consumers should check their inventory for the specific catalog and lot numbers listed above.

The recalled product

Product
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Manufacturer
Avid Medical, Inc.
Affected units
240

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog No. MCVA0089-04
  • LOT# 1027144

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →