Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues
Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.
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 a medical device where sterility cannot be assured, posing a risk of infection or harm. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 2,462 units of the Eye-Pak 7407 Tray Support Cover (REF 8065740745). The recall affects specific lot numbers: 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.
The recall was initiated because the peel pouches of the Tray Support Covers may be insufficiently sealed. This defect means that the sterility of the product cannot be assured, which is a critical requirement for medical devices used in surgical or clinical settings.
The affected products were distributed nationwide in the United States, as well as in Australia, Belgium, and Canada. Healthcare facilities and distributors should check their inventory for the specific item number and lot numbers listed above. If the product is found, it should be removed from use and returned to Alcon Research, Ltd. per the recall instructions.
The recalled product
- Product
- eye-pak 7407 Tray Support Cover REF 8065740745
- Manufacturer
- Alcon Research, Ltd.
- Category
- Medical Device — Surgical Trays
- Affected units
- 2,462
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 (7)
- Item Number 8065740745 with Lot numbers 613207-07V
- 613221-07V
- 613228-07V
- 613249-07V
- 613256-07V
- 35206V
- and 352699V.
Distribution
Distributed nationwide across the United States.
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