The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2913-2020·Announced 2020-09-09

Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 structural defect in a medical device intended for barrier protection in a high-risk environment (operating room). While no injuries are reported, the risk of contamination due to glove failure in a surgical setting fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling approximately 7,119,625 units of PROTEXIS Latex Micro Surgical Gloves, Size 6.0. The recall was initiated due to a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. The affected gloves are disposable devices made of natural rubber latex or synthetic rubber intended for use by operating room personnel as a barrier against contamination.

The recall covers specific lots of the gloves, including TS19060043, TS19060123, and others, with additional lots added as of October 20, 2020. The product was distributed nationwide in the United States. The defect compromises the integrity of the glove, which is designed to provide barrier protection during surgical procedures.

Healthcare facilities and consumers who have these specific lots of gloves should stop using them immediately. Cardinal Health is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - 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…
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 (20)

  • Item Code: 2D72NT60X Lot #: TS19060043
  • TS19060123
  • TS19060199
  • TS19070005
  • TS19070027
  • TS19070067
  • TS19070130
  • TS19070179
  • TS19070273
  • TS19080030
  • TS19090067
  • TS19090158
  • TS19090226
  • TS19090289
  • TS19110333
  • TS19120019
  • TS19120322
  • TS20020121
  • TS20030015
  • TS20030324 Additional Affected Lots as of 10/20/20: TS20040173

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 →

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