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.
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 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…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Gloves
- 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.
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