United StatesThe Tego Connector (REF 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego REF LAT-D1000) is being recalled — you can recognise affected devices by those reference numbers. The recall was issued because the connector’s silicone seal may bulge, separate from the body, or tear, which can cause fluid leaks, occluded fluid flow, inability to inject or withdraw blood, delayed or interrupted therapy, exposure to biological contaminants, or air being infused into the body.
What's being recalled
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Recalling firm: ICU Medical, Inc., San Clemente, CA, United States.
How to identify it
UDI-DI: 00840619026059, 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029), 14044313(6/1/2029), 14228823(12/1/2029), 14274294(1/1/2030); 01C-D1000/14171414(10/1/2029), 14304670(2/1/2030); 055-D1000/13772668(9/1/2028), 13778926(9/1/2028), 13791786(10/1/2028), 13794986(10/1/2028), 13797963(10/1/2028), 13801102(10/1/2028), 13806764(10/1/2028), 13812991(11/1/2028), 13822705(11/1/2028), 13828556(11/1/2028), 13833879(11/1/2028), 13838937(12/1/2028), 13867515(1/1/2029), 13875052(1/1/2029), 13876502(1/1/2029), 13876503(1/1/2029), 13882254(1/1/2029), 13882256(1/1/2029), 13887995(1/1/2029), 13887996(1/1/2029), 13894349(2/1/2029), 13894350(2/1/2029), 13903971(2/1/2029), 13903972(2/1/2029), 14045054(6/1/2029), 14045055(6/1/2029), 14049379(6/1/2029), 14049404(6/1/2029), 14063784(6/1/2029), 14063785(6/1/2029), 14071890(7/1/2029), 14071891(7/1/2029), 14071892(7/1/2029), 14087320(7/1/2029), 14090798(7/1/2029), 14110500(8/1/2029), 14131560(8/1/2029), 14144999(9/1/2029), 14145000(9/1/2029), 14150873(9/1/2029), 14150874(9/1/2029), 14150875(9/1/2029), 14170224(10/1/2029), 14170226(10/1/2029), 14179702(10/1/2029), 14179704(10/1/2029), 14179706(10/1/2029), 14208522(11/1/2029), 14208523(11/1/2029), 14212866(11/1/2029), 14212870(11/1/2029), 14216154(11/1/2029), 14216155(11/1/2029), 14224623(11/1/2029), 14248560(12/1/2029), 14248561(12/1/2029), 14274291(1/1/2030), 1427429291/1/2030), 14278257(1/1/2030), 14278258(1/1/2030), 14278259(1/1/2030), 14278260(1/1/2030), 14300970(2/1/2030), 14300972(2/1/2030), 14303936(2/1/2030); D1000/13768000(9/1/2028), 13772666(9/1/2028), 13778922(9/1/2028), 13778923(9/1/2028), 13778925(9/1/2028), 13791783(10/1/2028), 13791784(10/1/2028), 13791785(10/1/2028), 13792328(10/1/2028), 13794980(10/1/2028), 13794982(10/1/2028), 13794984(10/1/2028), 13801099(10/1/2028), 13801100(10/1/2028), 13801101(10/1/2028), 13806761(10/1/2028), 13806762(10/1/2028), 13806763(10/1/2028), 13812988(11/1/2028), 13812989(11/1/2028), 13812990(11/1/2028)…
The hazard
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada