Device Recall NAMIC Convenience Kit

Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30

Cardiovascular Devices

2

No

US Nationwide in the states of CA, IL, MA, SC, TX

NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 || Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

Batch/Lot No. 4925152, 4930012; Use By 2018-08

Cardiovascular Devices

2

No

US Nationwide in the states of CA, IL, MA, SC, TX

NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 || Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

Batch/Lot No. 4931728, 4933094; Use By 2017-03

Cardiovascular Devices

2

No

US Nationwide in the states of CA, IL, MA, SC, TX

NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF || Catalog No. 601319810, UPN Product No. H7496013198101 || Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.

Sterile/Non-Sterile UPN Cat Num Lot Sterile Kit H749600183811 60018381 4163389;  Sterile Kit H749600308161 60030816 4155011;  Sterile Kit H749600339121 60033912 4167674;  Sterile Kit H7496005216131 60052161 4148470;  Sterile Kit H7496005216131 60052161 4152176;  Sterile Kit H7496005216131 60052161 4166769;  Sterile Kit H7496005216131 60052161 4168829;  Sterile Kit H7496005216131 60052161 4170180;  Sterile Kit H749601621861 60162186 4173288;  Sterile Kit H749601921911 60192191 4155123;  Sterile Kit H749602103071 60210307 4155130;  Sterile Kit H749602103071 60210307 4160686;  Sterile Kit H749606912341 60691234 4175188;  Sterile Kit H965600102351 60010235 4155678;  Sterile Kit H965600104921 60010492 4153182;  Sterile Kit H965600204051 60020405 4155226;  Sterile Kit H965600204051 60020405 4172242;  Sterile Kit H965600206451 60020645 4155233;  Sterile Kit H965600300681 60030068 4166803;  Sterile Kit H965600800511 60080051 4155288;  Sterile Kit H965600800511 60080051 4169451;  Sterile Kit H965601001351 60100135 4154699;  Sterile Kit H965601001351 60100135 4165389;  Sterile Kit H965601001351 60100135 4168350;  Sterile Kit H965601001351 60100135 4169879;  Sterile Kit H965601001351 60100135 4172683;  Sterile Kit H965601001351 60100135 4176389;  Sterile Kit H965602100141 60210014 4160703;  Sterile Kit H965602201531 60220153 4155363;  Sterile Kit H965PK050455S1 PK050455S 4177156;  Non-Sterile Kit H749650300641 65030064 4148480;  Non-Sterile Kit H749650300641 65030064 4168790;  Non-Sterile Kit H749650302721 64030272 4167954;  Non-Sterile Kit H749651106561 65110656 4169591;  Non-Sterile Kit H749651106561 65110656 4172687;  Non-Sterile Kit H749656900411 65690041 4166791;  Non-Sterile Kit H965650200691 65020069 4169026;  Non-Sterile Kit H965651949131 65194913 4157481;  Non-Sterile Kit H965651949131 65194913 4174714;  Non-Sterile Kit H9656522016141 652201614 4167686; Non-Sterile Kit H9656522016141 652201614 4170421;

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, South Carolina, Wisconsin, Virginia and the country of Japan.

NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. || Product usage: For use in fluid management and/or invasive pressure monitoring systems