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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 Customedsee related information
Date Initiated by FirmMay 20, 2014
Date PostedAugust 29, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall NumberZ-2431-2014
Recall Event ID 68536
Product Classification Angiography/angioplasty kit - Product Code OEQ
ProductANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF (1) MOSQUITO HALSTED (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE (1) SCALPEL SAFETY #11 (3) LABELS FOR SKIN MARKER (1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2 (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz (4) BAND BAG WITH RUBBAND & TAPE LIF (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH (1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE (2) NEEDLE HYPODERMIC 23GA X 1" (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-2038, 21 lots: 112114658 112125063 113026054 113036790 113047157 113057456 113067865 113068044 113078304 113078602 113099284 113109785 131110231 131110604 131211016 131211023 140111450 140311934 140412464 140412897 140513123 
Recalling Firm/
Manufacturer
Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
For Additional Information ContactRosemari 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
ActionCustomed 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 Commerce21 lots/ 1196 units, multiple units per lot
DistributionWorldwide 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 CycleTPLC 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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