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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-2328-2014
Recall Event ID 68536
Product Classification laparoscopy kit - Product Code FDE
Product LAPAROSCOPY~OBPACK -
(4) ABSORBENT TOWELS 15" x 20" LIF
(2) LEGGINS WITH 7" CUFF
(1) LAPAROSCOPY T SHEET SMS
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(1) NEEDLE HYPODERMIC 18G X 1%
(1) *ROBIN REDRUBBER CATHETER 14FR LATEX
(1) DRAPE LASER CAMERA W/EL LIF
(1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF
(3) TOWEL CLAMP
(4) DRAPE UTILITY WITH TAPE LIF
(1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV
(2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV
(20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) TABLE COVER 44" X 90"
(1) MAYO STAND COVER REINFORCED LIF
(1) SURGICAL BLADE #15 CARBON STEEL
(1) LITE GLOVE LIF
(1) DRESSING NON-ADHESIVE TELFA 4" X 3"
(1) TUBE SUCTION CONNECT Y4" X 12' LIF

EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Code Information Product code 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845 
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 25 lots; 552 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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