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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-2310-2014
Recall Event ID 68536
Product Classification Obstetrical kit - Product Code OKV
ProductUniversal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36" X 77" (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24" X 24" (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Code Information Product code 900-169, 8 lots: 111010061 111040963 111071906 112041402 112051862 113036593 113046891 113088753 
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 Commerce8 lots; 120 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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