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U.S. Department of Health and Human Services

Class 2 Device Recall Incision and Drainage Tray

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 Class 2 Device Recall Incision and Drainage Traysee related information
Date Initiated by FirmDecember 08, 2011
Date PostedMarch 21, 2012
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-1258-2012
Recall Event ID 60753
Product Classification Tray, surgical, instrument - Product Code FSM
ProductIncision and Drainage Tray, catalog# 900-774
Code Information lot# 111030722, 111061688
Recalling Firm/
Manufacturer		 Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
Manufacturer Reason
for Recall		The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
FDA Determined
Cause 2		Packaging
ActionCustomed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.
Quantity in Commerce1,650 units
DistributionUSA Nationwide Distribution - including Florida and 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.
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