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U.S. Department of Health and Human Services

Class 1 Device Recall CATH TRAY

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 Class 1 Device Recall CATH TRAYsee related information
Date Initiated by FirmAugust 14, 2013
Date PostedFebruary 21, 2014
Recall Status1 Terminated 3 on December 19, 2017
Recall NumberZ-1050-2014
Recall Event ID 66080
Product Classification General surgery tray (kit) - Product Code LRO
ProductCATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Code Information Pack Number: DYNJ41101;  Lot: 13FB5744
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactMs. Kathy Dunne
866-359-1704
Manufacturer Reason
for Recall		Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, Medline Industries, Inc., sent a "RECALL IMMEDIATE ACTION REQUIRED" letter dated August 14, 2013, to its direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their stocks for inventory of the affected products, quarantine any affected products, return the product using the enclosed shipping slips for credit-If additional stickers are needed, please call 866-359-1704, and complete and return the enclosed FAX-BACK VERIFICATION FORM listing the quantity of affected product(s) on hand via fax to Medline at 866-767-1290. If you have any questions, please contact 866-359-1704.
Quantity in Commerce304 units
DistributionNationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
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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