CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Protexis Neoprene Surgical Glove recalled by Cardinal Health 200

Cardinal Health 200 is recalling Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored, distributed nationwide in the US. The recall was initiated on 31 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct code: 2D73DP55, Lot Numbers: TS18060249, TS18070244, TS18080021, TS18080344, and TS18090280.

Quantity recalled1,475,095 pairs 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-0631-2019
FDA event ID: 81579
Recalling firm: Cardinal Health 200, Waukegan, IL
Classification: Class II
Status: Terminated
Recall initiated: 31 Oct 2018
FDA classified: 18 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

31 Oct 2018	Recall initiated by company
18 Dec 2018	Classified by FDA	+48 days
26 Dec 2018	Published in enforcement report	+8 days

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

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Product as listed by the FDA

Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Where it was distributed

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

Product code: 2D73DP55, Lot Numbers: TS18060249, TS18070244, TS18080021, TS18080344, and TS18090280.

Where was it sold?

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 81579

This product is part of a recall event; the main page for the event is Protexis Neoprene Surgical Glove recalled by Cardinal Health 200.

Reported	Class	Recall	Company	Reason	Where
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
26 Dec 2018	CLASS II	Protexis Neoprene Surgical Glove recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide

More recalls from Cardinal Health 200

All 283

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide

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