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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-2346-2014
Recall Event ID 68536
Product Classification Orthopedic tray - Product Code OJH
ProductIMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Code Information Product code 900-741, 16 lots: 112041352 112072877 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736 
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 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
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 Commerce16 lots; 1041 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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