Alcon Custom-Pak Surgical Packs Recalled for Latex Glove Degradation
Alcon is recalling 16,971 Custom-Pak Surgical Procedure Packs containing Cardinal Health PROTEXIS Latex Micro Surgical Gloves due to a degradation defect that could cause holes or tears.
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 is classified as FDA Class II, and the source text identifies a risk of infection and exposure to body fluids without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, LLC is recalling 16,971 Alcon Custom-Pak Surgical Procedure Packs that contain Cardinal Health PROTEXIS Latex Micro Surgical Gloves. These packs are used by ophthalmic surgeons in various ophthalmic surgeries.
The recall is due to a degradation defect in the third-party brand latex micro surgical gloves. This defect could lead to holes and donning tears at the folding area around the cuffs. Such failures could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
The affected products were distributed nationwide in the United States, including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, and WV. Healthcare facilities should check their inventory against the specific Pak and lot numbers listed in the official recall notice and stop using the affected packs.
The recalled product
- Product
- Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
- Manufacturer
- Alcon Research, LLC
- Category
- Medical Device — Surgical Gloves
- Affected units
- 16,971
Distribution
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