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Terminated

Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

FDA Recall Z-1837-2017 · Posted None

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodePAX
Date Initiated2017-03-27
Date Terminated2017-12-05
Product Quantity561,702

Reason for Recall

Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.

Firm Action

Alcon sent an Urgent Voluntary Medical Device Recall letters dated March 23, 2017 to customers. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignees to quarantine and return any unused products of the items/lots listed in the letter. For questions contact Customer Service at 1-800-862-5266.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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