| | Class 2 Device Recall Tego Connector |  |
| Date Initiated by Firm | December 19, 2025 |
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| Date Posted | January 16, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1111-2026 |
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| Recall Event ID |
98150 |
| 510(K)Number | K053106 |
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| Product Classification |
Set, administration, intravascular - Product Code FPA
|
| Product | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 |
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| Code Information |
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), 13822693(11/1/2028), 13822697(11/1/2028), 13822701(11/1/2028), 13825588(11/1/2028), 13828548(11/1/2028), 13828551(11/1/2028), 13828553(11/1/2028), 13833876(11/1/2028), 13833877(11/1/2028), 13833878(11/1/2028), 13838931(11/1/2028), 13838933(12/1/2028), 13838935(11/1/2028), 13848442(12/1/2028), 13848444(12/1/2028), 13848445(12/1/2028), 13854647(12/1/2028), 13854648(12/1/2028), 13854649(12/1/2028), 13858987(12/1/2028), 13859857(12/1/2028), 13859858(12/1/2028), 13859859(12/1/2028), 13867512(1/1/2029), 13867514(1/1/2029), 13876507(1/1/2029), 13876508(1/1/2029), 13876509(1/1/2029), 13882259(1/1/2029), 13882260(1/1/2029), 13887205(1/1/2029), 13887206(1/1/2029), 13887997(1/1/2029), 13894351(1/1/2029), 13894352(2/1/2029), 13894353(2/1/2029), 13903974(2/1/2029), 13903975(2/1/2029), 13903976(2/1/2029), 13903977(2/1/2029), 13910270(2/1/2029), 13910272(2/1/2029), 13938363(3/1/2029), 13938364(3/1/2029), 13938366(3/1/2029), 13943704(3/1/2029), 13943708(3/1/2029), 13943712(3/1/2029), 13943720(3/1/2029), 13949234(3/1/2029), 13953949(3/1/2029), 13953954(4/1/2029), 13953956(4/1/2029), 13953958(4/1/2029), 13955847(4/1/2029), 13959937(4/1/2029), 13959944(4/1/2029), 13959950(4/1/2029), 13959956(4/1/2029), 13971720(4/1/2029), 13971744(4/1/2029), 13971752(4/1/2029), 13971761(4/1/2029), 13971773(4/1/2029), 13979279(4/1/2029), 13979290(4/1/2029), 13979293(4/1/2029), 13979298(4/1/2029), 13979303(4/1/2029), 13979306(4/1/2029), 13979308(4/1/2029), 13982887(4/1/2029), 13982888(4/1/2029), 13986330(4/1/2029), 13986339(4/1/2029), 13986376(5/1/2029), 13986393(4/1/2029), 13986399(4/1/2029),13986406(4/1/2029), 13986440(4/1/2029), 13999996(5/1/2029), 13999997(5/1/2029), 13999999(5/1/2029), 14000000(5/1/2029), 14000001(5/1/2029), 14000002(5/1/2029), 14000003(5/1/2029), 14015459(5/1/2029), 14015462(5/1/2029), 14015463(5/1/2029), 14015464(5/1/2029), 14015467(5/1/2029), 14021608(5/1/2029), 14021610(5/1/2029), 14021611(5/1/2029), 14021612(5/1/2029), 14021613(5/1/2029), 14027546(5/1/2029), 14027547(5/1/2029), 14027548(5/1/2029), 14027549(5/1/2029), 14027551(5/1/2029), 14027552(5/1/2029), 14027553(5/1/2029), 14036497(5/1/2029), 14036498(5/1/2029), 14036499(5/1/2029, 14036500(6/1/2029), 14036501(6/1/2029), 14036502(6/1/2029), 14036503(6/1/2029), 14037604(6/1/2029), 14037605(6/1/2029), 14041790(6/1/2029), 14041792(6/1/2029), 14041793(6/1/2029), 14041795(6/1/2029), 14041797(6/1/2029), 14041798(6/1/2029), 14041800(6/1/2029), 14056392(6/1/2029), 14056393(6/1/2029), 14056395(6/1/2029), 14056397(6/1/2029), 14056398(6/1/2029), 14056399(6/1/2029), 14056400(6/1/2029), 14063790(6/1/2029), 14063791(7/1/2029), 14063792(7/1/2029), 14071894(7/1/2029), 14071895(7/1/2029), 14087321(7/1/2029), 14087322(7/1/2029), 14087323(7/1/2029), 14090800(7/1/2029), 14090801(8/1/2029), 14097661(8/1/2029), 14097662(8/1/2029), 14100193(8/1/2029), 14100198(8/1/2029), 14110501(8/1/2029), 14110502(8/1/2029), 14110503(8/1/2029), 14110505(8/1/2029), 14115072(8/1/2029), 14115073(8/1/2029), 14115074(8/1/2029), 14115075(8/1/2029), 14115076(8/1/2029), 14131561(8/1/2029), 14131562(9/1/2029), 14131563(9/1/2029), 14131564(9/1/2029), 14135720(9/1/2029), 14135721(9/1/2029), 14135722(9/1/2029), 14135723(9/1/2029), 14135725(9/1/2029), 14145003(9/1/2029), 14145004(9/1/2029), 14145005(9/1/2029), 14147959(9/1/2029), 14150877(9/1/2029), 14150878(10/1/2029), 14150880(9/1/2029), 14162155(10/1/2029), 14170227(10/1/2029), 14170231(10/1/2029), 14170232(10/1/2029), 14179721(10/1/2029), 14183938(10/1/2029), 14183940(10/1/2029), 14183941(10/1/2029), 14192702(10/1/2029), 14192703(10/1/2029), 14201160(11/1/2029), 14201161(11/1/2029), 14201162(11/1/2029), 14201163(11/1/2029), 14201165(11/1/2029), 14216156(11/1/2029), 14216157(11/1/2029), 14219693(11/1/2029), 14219694(11/1/2029), 14224627(11/1/2029), 14224630(11/1/2029), 14226006(11/1/2029), 14226007(11/1/2029), 14226008(11/1/2029), 14226009(11/1/2029), 14226010(11/1/2029), 14226011(12/1/2029), 14226012(12/1/2029), 14226013(12/1/2029), 14228825(12/1/2029), 14228826(12/1/2029), 14228828(12/1/2029), 14228832(12/1/2029), 14244970(12/1/2029), 14244971(12/1/2029), 1424497(12/1/2029), 14244977(12/1/2029), 14244978(12/1/2029), 14244980(12/1/2029), 14251976(12/1/2029), 14251977(12/1/2029), 14251979(12/1/2029), 14251980(12/1/2029), 14251983(12/1/2029), 14251984(12/1/2029), 14251985(1/1/2030), 14251986(12/1/2029), 14265939(1/1/2030), 14265940(1/1/2030), 14265941(1/1/2030), 14265942(1/1/2030), 14265943(1/1/2030), 14289207(1/1/2030), 14292935(2/1/2030), 14292936(2/1/2030), 14300977(2/1/2030), 14300979(2/1/2030), 14307683(2/1/2030), 14307684(2/1/2030), 14307685(2/1/2030);
LAT-D1000/13768003(9/1/2028), 13778927(10/1/2028), 13812992(11/1/2028), 13848447(12/1/2028), 13867516(1/1/2029), 14015450(5/1/2029), 14044312(6/1/2029), 14063789(6/1/2029), 14090799(7/1/2029), 14145002(9/1/2029), 14228820(12/1/2029), 14228821(12/1/2029), 14228822(12/1/2029), 14274293(1/1/2030), 14274302(1/1/2030), 14307682(2/1/2030)
|
| FEI Number |
2025816
|
Recalling Firm/
Manufacturer |
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
|
Manufacturer Reason
for Recall | 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 |
|---|
FDA Determined
Cause 2 | Process control |
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| Action | On 12/19/2025, correction notices were emailed to customers who were asked to do the following:
1) Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal.
2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there.
3) Complete and return the Customer Response Form via email to marketaction@mailac.custhelp.com
For further inquiries, please contact the firm:
Global Complaint Management: productcomplaintspp@icumed.com 1-(866)-216-8806; Customer Service: customerservice@icumed.com, 1-(800)-258-5361 |
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| Quantity in Commerce | 14,684,607 items |
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| Distribution | 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.
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FPA
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