CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report

Protexis Latex Micro Surgical Gloves Size recalled

Cardinal Health 200 is recalling Protexis Latex Micro Surgical Gloves Size 8.5, distributed nationwide in the US. The recall was initiated on 29 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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

Quantity recalled7119625 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2918-2020
FDA event ID: 86131
Recalling firm: Cardinal Health 200, Waukegan, IL
Classification: Class II
Status: Completed
Recall initiated: 29 Jul 2020
FDA classified: 28 Aug 2020
Reported: 9 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Surgical Instruments

Timeline

29 Jul 2020	Recall initiated by company
28 Aug 2020	Classified by FDA	+30 days
9 Sep 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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 sensitivity or durability depending on need.

Where it was distributed

US Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Which lots are affected?

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

Where was it sold?

US Nationwide distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 86131

This product is part of a recall event; the main page for the event is Protexis Latex Micro Surgical Gloves Size recalled.

Reported	Class	Recall	Company	Reason	Where
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide
9 Sep 2020	CLASS II	Protexis Latex Micro Surgical Gloves Size recalled	Cardinal Health 200	Potency & Assay	Nationwide

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All 283

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