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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-2389-2014
Recall Event ID 68536
Product Classification Cardiovascular surgical instruments tray (kit) - Product Code OFA
Product OPEN HEART TRAY - - PACK A

( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF
(5) DRAPE % ECONOMY 53" X 77" LIF
( 1) MAYO STAND COVER REINFORCED LIF
(7) DRAPE UTILITY WITH TAPE L/F
(8) HUCK CLOTH TOWELS WHITE L/F
(20) HUCK CLOTH TOWELS BLUE LIF
(1) MAYO TRAY LARGE LIF
(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF
(6) 3/4 SHEET DRAPE REINFORCED LIF
(2) STOCKINETTE 9" X 48" LIF
(1) SPLIT SHEET BILATERAL 84" X 80" LIF
(3) DRAPE SHEET 41" X 58" SMS LIF
(4) Pr. GLOVES SURGEON #7 BIOGEL

OPEN HEART TRAY - HOSPITAL DAMAS - PACK B-

(1) PLASTIC RULER 12" LONG
(2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F
(1) Pk. PEANUT SPONGE DISSECTOR ST.
(2) UTILITY BOWL 32 oz. LIF
(1) SKIN MARKER WITH RULER LIF
(2) UTILITY BOWL 16 oz. UF
(3) BULB SYRINGE 60cc UF
(1) MAYO TRAY SMALL L/F
(2) YANKAUER SUCT. TUBE WITHOUT VENT UF
(1) TRAY ORGANIZER FULL DEEP LIF
(5) SAPHENOUS VEIN CANNULA LIF
(40) LAP SPONGES PRE-WASH XRD UF
(2) ELASTIC BANDAGE 6" X 5 yds. UF
(2) SUTURE BAG FLORAL
(2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF
(1) BLADE SHARP ALL ARROUND 69
(1) SURGICAL BLADE# 11 CARBON STEEL
(4) LITE GLOVES UF
(2) SURGICAL BLADE# 15 CARBON STEEL
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL
(1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF
(2) POUCH INSTRUMENT
(2) SURGICAL BLADE# 10 CARBON STEEL
(30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF
(2) CAUTERY PENCIL ROCKER SWITCH LIF
(2) POLISHER CAUTERY TIP UF
(1) LABEL SET, HEPARINE,SALINE
(2) ELASTIC BANDAGE 4" X 5 yds. LIF
(1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF
(2) COTION GLOVE HEAVY DUTY
(1) AORTIC MONITORING PRESS SET 5.0
(1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF
(2) NEEDLE HYPODERMIC 22G X 1 % LIF
(1) BLADE 6.1 X 32.3 X 1.0MM
(1) SQUARE TWO PIECE 500cc GRADUATE
(2) CONNECTOR REDUCER
(1) NEEDLE BLADE/KNIFE 3.0MM

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718 
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 6 lots; 127 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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