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Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medi...

FDA Device Recall #Z-1837-2017 — Class II — March 27, 2017

Recall Summary

Recall Number Z-1837-2017
Classification Class II — Moderate risk
Date Initiated March 27, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alcon Research, Ltd.
Location Fort Worth, TX
Product Type Devices
Quantity 561,702

Product Description

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

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.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

SPCK50319 SPCK50317 SPCK50304 SPCK50277 SPCK50263 SPCK50262 SPCK50244 SPCK50241 SPCK50233 SPCK50229 SPCK50227 SPCK50224 SPCK50223 SPCK50221 SPCK50218 SPCK50208 SPCK50207 SPCK50205 SPCK50203 SPCK50202 SPCK50198 SPCK50196 SPCK50193 SPCK50192 SPCK50187 SPCK50182 SPCK50180 SPCK50177 SPCK50176 SPCK50174 SPCK50172 SPCK50171 SPCK50168 SPCK50164 SPCK50162 SPCK50155 SPCK50149 SPCK50148 SPCK50142 SPCK50141 SPCK50135 SPCK50134 SPCK50129 SPCK50128 SPCK50126 SPCK50119 SPCK50115 SPCK50113 SPCK50112 SPCK50107 SPCK50103 SPCK50102 SPCK50100 SPCK50099 SPCK50097 SPCK50096 SPCK50094 SPCK50091 SPCK50083 SPCK50075 SPCK50073 SPCK50070 SPCK50065 SPCK50063 SPCK50059 SPCK50053 SPCK50048 SPCK50044 SPCK50031 SPCK50030 SPCK50022 SPCK50021 SPCK50013 SPCK50004 SPCK43027 SPCK42997 SPCK42948 SPCK42836 SPCK42779 SPCK42721 SPCK42701A SPCK42610 SPCK42604 SPCK42593 SPCK42548 SPCK42543 SPCK42504 SPCK42496 SPCK42491 SPCK42448A SPCK42425 SPCK42065A SPCK41975 SPCK41932A SPCK41916C SPCK41895A SPCK41877A SPCK41842 SPCK41816A SPCK41734 SPCK41712A SPCK41570A SPCK41313A SPCK41304 SPCK41102A SPCK41018 SPCK40978 SPCK40945 SPCK40846A SPCK40759A SPCK40647A SPCK40644A SPCK40585 SPCK40572B SPCK40449 SPCK40401A SPCK40288B SPCK40170B SPCK40161 SPCK40157B SPCK40105 SPCK40102B SPCK40096B SPCK02117

Other Recalls from Alcon Research, Ltd.

Recall # Classification Product Date
Z-2408-2023 Class II Infinity FMS Pak Jun 28, 2023
Z-2407-2023 Class II Centurion FMS Pak Jun 28, 2023
Z-2406-2023 Class II Constellation Procedure Pak Jun 28, 2023
Z-2410-2023 Class II Phaco Standalone Tips Jun 28, 2023
Z-2411-2023 Class II Alcon Custom Pak Jun 28, 2023

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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