The Recall Desk
HighFDA (Devices)·Z-2912-2020·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 could cause holes or tears at the cuffs, compromising barrier protection.

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 risk-of-harm product (surgical gloves) where the defect compromises barrier protection, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves, Size 5.5. The recall involves 7,119,625 units distributed nationwide in the United States. The affected lots include TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092, TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, and TS20070125.

The recall was initiated because a degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. These gloves are disposable devices made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to provide barrier protection from contamination.

Healthcare facilities and users should stop using the affected gloves and contact Cardinal Health for further instructions. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - 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 (16)

  • Item Code: 2D72NT55X Lot #: TS19060338
  • TS19070077
  • TS19070176
  • TS19090164
  • TS19090248
  • TS19100272
  • TS19110080
  • TS20010146
  • TS20020202
  • TS20040092 Additional Affected lots as of 10/20/20: TS20040247
  • TS20050050
  • TS20050051
  • TS20050261
  • TS20060112
  • TS20060113
  • TS20070125

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

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Same hazard · material degradation

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