The Recall Desk
HighFDA (Devices)·Z-2918-2020·Announced 2020-09-09

Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.

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 is classified as FDA Class II, and the defect poses a risk of harm by compromising the protective barrier of the surgical gloves, although no specific injuries are reported in the source text.

Plain-English summary

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves, Size 8.5. The recall involves approximately 7,119,625 units that were distributed nationwide in the United States. The affected product is a disposable surgical glove made of natural rubber latex or synthetic rubber, intended for use by operating room personnel as a barrier against contamination.

The recall was initiated because a degradation defect was identified that could lead to holes and donning tears at the folding area around the cuffs. This defect compromises the integrity of the glove, potentially reducing its effectiveness as a protective barrier.

Healthcare facilities and consumers who have purchased these gloves should stop using them immediately. Affected lots include TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139, TS20050169, TS20050262, and TS20060005. The item code is 2D72NT85X. Users should contact Cardinal Health 200, LLC for further instructions on returning or disposing of the product.

The recalled product

Product
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Gloves
Hazard
Affected units
7,119,625

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 (18)

  • Item Code: 2D72NT85X Lot #: TS19060044
  • TS19060122
  • TS19060189
  • TS19080111
  • TS19080184
  • TS19080227
  • TS19090008
  • TS19090127
  • TS19100079
  • TS19100220
  • TS19110109
  • TS19110285
  • TS19110331
  • TS19120316
  • TS20050031
  • TS20050139 Additional Affected Lots as of 10/20/20: TS20050169
  • TS20050262
  • TS20060005

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Cardinal Health 200, LLC 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 8 products in this recall →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

See all →

Same hazard · structural defect

See all →