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U.S. Department of Health and Human Services

Class 2 Device Recall Packaged Kits

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  Class 2 Device Recall Packaged Kits see related information
Date Initiated by Firm March 27, 2017
Create Date April 18, 2017
Recall Status1 Terminated 3 on December 05, 2017
Recall Number Z-1837-2017
Recall Event ID 76855
Product Classification Surgical Kit - Product Code PAX
Product 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
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 
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Sevice
800-862-5266
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 561,702
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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