Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling
Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.
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 allergen mislabeling (latex) on a medical device, which fits the rubric criteria for 'High' severity (allergen mislabeling on common allergens). No illnesses or injuries are reported in the source text.
Plain-English summary
Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27, a single-use medical device and accessory set designed for specific ophthalmic surgical procedures. The recall is due to a labeling error where the devices are marked as latex-free but actually contain latex gloves instead of the specified non-latex gloves.
The affected units were distributed in Vermont. The specific lot codes involved are 1792733H, 1783925H, 1785227H, and 1786729H. This mislabeling poses a risk to patients or healthcare professionals with latex allergies who may be exposed to the latex gloves during the surgical procedure.
Healthcare facilities and consumers who have these specific units should stop using them immediately and contact Alcon Research, Ltd. for further instructions on how to return or dispose of the product. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 5
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 (4)
- 1792733H
- 1783925H
- 1785227H
- 1786729H
Distribution
Distributed in 1 state:
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