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U.S. Department of Health and Human Services

Class 2 Device Recall PORTACATH Plastic Hub Needles

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  Class 2 Device Recall PORTACATH Plastic Hub Needles see related information
Date Initiated by Firm September 14, 2015
Date Posted October 21, 2015
Recall Status1 Terminated 3 on May 09, 2016
Recall Number Z-0152-2016
Recall Event ID 72112
510(K)Number K830730  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24

The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.
Code Information Lot 46262
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Customer Service
800-258-5361
Manufacturer Reason
for Recall		 The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/2015 to customers. The letter described the product, problem, and actions to be taken. The customers were instructed to Inspect your inventory for and quarantine the affected product, complete and return attached Confirmation form via fax to: 1-651-747-4959 or email to: recall.response@smiths-medical.com within 10 days; upon receipt of completed form, customer representative will contact you and arrange for exchange of your unused affected product; send a copy of letter and confirmation form to your customers identified, replacement product will be arranged for your customers; provide email confirmation of your customer notification to Smiths Medical at recall.response@smiths-medical.com, and notify downstream customers who may have received the product. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at 1-800-258-5361.
Quantity in Commerce 130 Cartons (1560 needles)
Distribution Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LJT and Original Applicant = PHARMACIA, INC.
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