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U.S. Department of Health and Human Services

Class 2 Device Recall Customed

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 Class 2 Device Recall Customedsee related information
Date Initiated by FirmJanuary 07, 2016
Date PostedApril 14, 2016
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1474-2016
Recall Event ID 72992
510(K)NumberK971920 
Product Classification Gown, surgical - Product Code FYA
ProductCatalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Code Information LOTS: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16 
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
Manufacturer Reason
for Recall		Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
FDA Determined
Cause 2		Packaging
ActionRecall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
Quantity in Commerce5712
DistributionDistributed only in Puerto Rico.
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.
510(K) Database510(K)s with Product Code = FYA
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