Surgical Procedure Pack Contains Latex Despite 'Latex-Free' Label
Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.
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: This is FDA Class II with allergen mislabeling on a common allergen (latex). The severity rubric identifies allergen mislabeling on common allergens without reported illness as High (3) severity.
Plain-English summary
Alcon Research, LLC is recalling custom surgical procedure packs (REF 14057-09) due to a mislabeling error. The packs contain latex gloves but are labeled as 'latex-free.'
This creates a hazard for healthcare workers and patients with latex allergies. Individuals who rely on the 'latex-free' label to avoid latex exposure may be unknowingly exposed and experience allergic reactions.
The affected product (lot 160NMU) was distributed to surgical centers in Virginia. A total of 120 packs were distributed.
Healthcare facilities that received these packs should immediately stop using them and contact Alcon to report the incident and request replacement 'latex-free' packs. Healthcare workers and patients who have been exposed to the product should monitor for allergic reaction symptoms and seek medical attention if symptoms occur.
The recalled product
- Product
- Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
- Manufacturer
- Alcon Research, LLC
- Affected units
- 120
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 (2)
- LOT # : 160NMU
- UDI: (01)10380653302278
Distribution
Distributed in 1 state:
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