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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-2433-2014
Recall Event ID 68536
Product Classification Cardiovascular surgical instruments tray (kit) - Product Code OFA
Product OPEN HEART TRAY
PACK A
CONTENTS:
(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F
(3) TOWEL ABSORBENT 15" X 20" LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80"
(12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE
(1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE
(4) TOWELS CLOTH HUCK WHITE
(2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54"
(3) LITES GLOVE LIF

OPEN HEART TRAY
HOSPITAL HERMANOS MELENDEZ
PACKB

CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH
(2) PENCIL CAUTERY ROCKER SWITCH LIF
(3) TUBE SUCTION CONNECT W X 12' LIF
(2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE
(2) CAUTERY TIP POLISHER LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF
(2) YANKAUER SUCTION TUBE WITHOUT VENT LIF
(2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST.
(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) NEEDLE HYPODERMIC 27G X %" ST.
(1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz.
(4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc
(1) TRAY PLATFORM LARGE
(1) SKIN MARKER WITH RULER
(1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF
(1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL

OPEN HEART TRAY
HOSPITAL HERMANOS MELENDEZ
PACKC
CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF
(6) GOWN FAB REINFORCED SONTARA X-LARGE
(1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill
(1) TABLE COVER REINFORCED 44" X 78" UF


Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-2114, 12 lots 112030719 112041222 112051939 112083124 112093924 112125069 113025796 113026055 113026076 113036761 113057459 113088787 
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 differ 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 12 lots/88 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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