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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-2455-2014
Recall Event ID 68536
Product Classification Ear, nose, and throat surgical tray (kit) - Product Code OGR
Product EAR PACK
CONTENTS:
(I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc
(2) LABEL FOR SKIN MARKERS
( I) NEEDLE HYPODERMIC 1 80 X I Y,
( I) WASI-l BASIN ROUND 6QT
(I) INSTRUMENT POUCH 7 X I I 2 COMPART
(I) STRIP STER I CLOSURE W' X 4" LIF
(I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF
( I) SH EET ENT SPLIT 11 0 X 77
(2) LITE GLOVE
(2) NEEDLE H YPODERM IC 27G X I \!..''
(1 2) TOWELS CLOTH HUCK (BLUE)
( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF
( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF
(4) COTrON APPLICATOR 6" WOOD
( I ) INSTRUMENT WIPE I MM 8.25 X 8.25
( I ) MAYO STAND COYER REINFORCED LIF
( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER
( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF
( I ) TRAY MAYO SMALL
( I ) SYRING E IOcc TI P CONTROL LILOCK LIF
( I ) DRAPE MICROSCOPE ZEI SS
( I ) TOWELS ABSORBENT 1 5'' X 20" LIF
( I ) TIME OUT BEACON NON WOV EN ST LIF
( I ) BLADE M INUATURE CARBON STEEL
( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF
( I ) NEEDLE BLUNT FI LL 1 80 X I Y,
(2) SCALPEL SAFETY WEIGHTED # 1 5
( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL
( I ) MERLINO SKIN PREP APPLIC. 39ML LIF
( I ) WRAPPER 24" X 24"

WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30"
( I ) TRAY 3/COMPARTM ENT
( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE
(3) TI P ABSORBENT APPLICATOR STICK SPONGE
(3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF
(2) GLOVE MED FREETOUCI-1 VYN I L P/F
(2) COTrON APPLICATOR 6" WOOD

Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-2423 ,3 lots 131010019 140111210 140312131  
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 3 lots/27 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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