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U.S. Department of Health and Human Services

Class 1 Device Recall Customed

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  Class 1 Device Recall Customed see related information
Date Initiated by Firm May 20, 2014
Date Posted August 29, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-2361-2014
Recall Event ID 68536
Product Classification Eye tray - Product Code OJK
Product CATARACT PACK- OJOS INC.-
(1) TABLE COVER REINF. 44" X 78" L/F
(2) MEDICINE CUP 1oz.
(2) ABSORBENT TOWEL 15" X 20" LIF
(1 0) EYE SPEAR MICRO SPONGE
(1) EYE PAD 2 1/8 X 2 5/8 LIF
(4) DRAPE UTILITY LIF
(1) EYE SHIELD UNIVERSAL
(2) GOWN LGE STANDARD SMS VELCRO/NECK
(1) MAYO STAND COVER REINF. LIF
(1) EYE DRAPE LIF
(1) SYRINGE 3cc W/0 NDL L/LOCK LIF
(1) WIPE INSTRUMENT 1MM L/F

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-944, 63 lots: 110010120 110010151 110020418 110020489 110020494 110040959 110040961 110041046 110041047 110061499 110061544 110071716 110071717 110071807 110071808 110092290 110092318 110092409 110092412 110112786 110112787 110122904 110122905 111010173 111010179 111020306 111030826 111040980 111051219 111061648 111071971 111082117 111092408 111102641 111102787 111123307 112010211 112020471 112030755 112030944 112041363 112052025 112062574 112083442 112104089 112114686 113025972 113036598 113047119 113047149 113057515 113057821 113068182 113078576 113099299 113099580 131210848 131210975 140111456 140211881 140312387 140412843 140513353
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
For Additional Information Contact Rosemari Melendez
787-622-5151 Ext. 7540
Manufacturer Reason
for Recall		 Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
FDA Determined
Cause 2		 Package design/selection
Action Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
Quantity in Commerce 63 lots; 20094 units (multiple units per lot)
Distribution Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
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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