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U.S. Department of Health and Human Services

Class 2 Device Recall Port Kit with Access Infusion Set

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 Class 2 Device Recall Port Kit with Access Infusion Setsee related information
Date Initiated by FirmNovember 25, 2013
Date PostedJanuary 24, 2014
Recall Status1 Terminated 3 on March 10, 2017
Recall NumberZ-0826-2014
Recall Event ID 67122
510(K)NumberK100720 K122767 K131694 
Product Classification Set, administration, intravascular - Product Code FPA
ProductPort Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Code Information Batch/Lot Numbers: 4688881, 4688883, 4688884, 4688885, 4688887, 4668695, 4654060, 4654060, 4659108, 4668699, 4654061, 4659109, 4668700, 4654062, 4659110, 4668701, 4654063, 4658398, 4662581, 4664985, 4675021, 4681156, 4654064, 4654065, 4658399, 4658400, 4662583 and 4675023
Recalling Firm/
Manufacturer		 Navilyst Medical, Inc.
26 Forest St
Marlborough MA 01752-3068
For Additional Information ContactMichael Duerr
508-658-7990
Manufacturer Reason
for Recall		Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
FDA Determined
Cause 2		Device Design
ActionNavilyst Medical, Inc., sent an Urgent Medical Device Recall - Immediate Action Required letter dated November 25, 2013 to their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers are instructed to segregate and return all affected devices to Navilyst Medical, Inc. Distribution Center Attn: QA Returns 10 Glens Falls Technical Park Glens Falls, NY 12801 and complete and return the Reply Verification Tracking Form provided in the recall notification via Fax to: 1-800-782-1357. For questions call 1-800-833-9973 between 8:30 am and 7:00 pm (EST).
Quantity in Commerce920 Total kits
DistributionUS Nationwide Distribution in the states of CA, CT, DC, MA, NJ, NY, PA, MD, VA, WV, NC, GA, FL, TN, OH, MN, MT, IL, MO, NE, OK, TX, NM, and WA.
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 = FPA
510(K)s with Product Code = FPA
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