openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 20
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3002. a. Lot Number 3326545, UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545, Expiration Date 09/01/2021; b. Lot Number 3459161, UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161, Expiration Date 05/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 2 of 20
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3003. Lot Number 3297342, UDI Number (01) 1 0840619 09275 1 (17) 210700 (30) 50 (10) 3597342, Expiration Date 07/01/2021.
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 3 of 20
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3003. a. Lot Number 3303902, UDI Number (01)1 0840519 09277 6 (17)210800 (30) 50 (10) 3303902, Expiration Date 08/01/2021; b. Lot Number 3380550, UDI Number (01) 1 0840619 09277 8 (17) 211201 (30) 50(10) 3380550, Expiration Date 12/01/2021
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 4 of 20
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3006. Lot Number 3508532, UDI Number (01) 1 0840619 09320 1 (17) 220601 (30) 20 (10) 3508532 , Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 5 of 20
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3010. Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 6 of 20
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM3011. Lot Number 3408988, UDI Number (01) 1 0840619 09531 1 (17) 220201 (30) 50 (10) 3408988, Expiration Date 02/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 7 of 20
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6111. a. Lot Number 3442842, UDI Number (01) 1 0840619 08918 1 (17) 220501 (30) 50 (10) 3442842, Expiration Date 05/01/2021; b. Lot Number 3508246, UDI Number (01) 1 0840619 08918 1 (17) 220801 (30) 50 (10)3508246, Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 8 of 20
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6116. a. Lot Number 3380551, UDI Number (01) 1 0840619 09274 7 (17) 211201 (30) 50 (10) 3380551, Expiration Date 12/01/2021; b. Lot Number 3493462, UDI Number (01) 1 0840619 09274 7 (17) 220701 (30) 50 (10) 3493482, Expiration Date 07/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 9 of 20
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6118. a. Lot Number 3358780, UDI Number (01)01 0840619 09319 (17) 211101 (30) 50 (10) 3358780, Expiration Date 11/01/2021; b. Lot Number 3365174, UDI Number (01) 01 0840619 09319 5 (17) 211101 (30)50 (10) 3365174, Expiration Date 11/01/2021; c. Lot Number 3367857, UDI Number (01) 01 0840619 09319 8 (17) 211101 (30) 01 (10) 3387857, Expiration Date 11/01/2021; d. Lot Number 3497708, UDI Number (01) 1 0840619 09319 5 (17) 220701 (30) 50 (10) 3497708, Expiration Date 07/01/2022; e. Lot Number 3508531, UDI Number (01) 1 0840619 09319 5 (17) 220801 (30) 50 (10) 3508531, Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6123. a. Lot Number 3393136, UDI Number (01) 1 0840619 09404 8 (17) 220101 (30) 20 (10) 3393136, Expiration Date 11/01/2022; b. Lot Number 3508527, UDI Number (01) 1 0840619 09404 8 (17) 220801 (30) 20 (10) 3508527, Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 11 of 20
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6125. Lot Number 3424313, UDI Number (01) 1 0840619 09486 4 (17) 220301 (30) 50 (10) 342313, Expiration Date 03/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 12 of 20
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number011-AM6126. a. Lot Number 3409000, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10) 3409000, Expiration Date 02/01/2022; b. Lot Number 3446970, UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10)3446970, Expiration Date 05/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number011-AM6129. Lot Number 3459160, UDI Number (01) 1 0840619 09605 2 (17) 220501 (30) 01 (10) 3459160, Expiration Date 05/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 14 of 20
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6132. a. Lot Number 3484175, UDI Number (01) 1 0840619 09743 6 (17) 220601 (30) 50 (10) 3484175, Expiration Date 07/01/2022; b. Lot Number 3493946, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3493946, Expiration Date 07/01/2022; c. Lot Number 3498103, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3498103, Expiration Date 07/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 15 of 20
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number 011-AM6133. a. Lot Number 3493948, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3493948, Expiration Date 07/01/2022; b. Lot Number 3498107, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3498107, Expiration Date 07/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number AM6100. a. Lot Number 3373756, UDI Number (01) 1 0887709 07066 7 (17) 211201 (30) 50 (10) 3373756, Expiration Date 12/01/2021; b. Lot Number 3423328, UDI Number (01) 1 0887709 07066 7 (17) 211401 (30) 50 (10) 3423328, Expiration Date 04/01/2022; c. Lot Number 3446319, UDI Number (01) 1 0887709 07066 7 (17) 211501 (30) 50 (10) 3446319, Expiration Date 05/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number AM6109. a. Lot Number 3373758, UDI Number (01) 1 0887709 07764 2, Expiration Date 12/01/2021; b. Lot Number 3391364, UDI Number (01) 1 0887709 07764 2 (17) 220101 (30) 50 (10) 3391364, Expiration Date 01/01/2022; c. Lot Number 3511445, UDI Number (01) 1 0887709 07764 2 (17) 220801 (30) 50 (10) 3511445, Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number AM6127. a. Lot Number 3379607, UDI Number (01) 1 0887709 08635 4 (17) 211201 (30) 50 (10) 3379607, Expiration Date 12/01/2021; b. Lot Number 3436226, UDI Number (01) 1 0887709 08635 4 (17) 220401 (30) 50 (10) 3436226, Expiration Date 04/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
device · product 19 of 20
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number AM6128. a. Lot Number 3423330, UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330, Expiration Date 04/01/2022; b. Lot Number 3476737, UDI Number (01) 1 0887709 08696 5 (17) 220601 (30) 50 (10) 3476737, Expiration Date 06/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
These labels are deterministic app interpretations, not FDA categories.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Code information
Item Number AM6130. a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Expiration Date 02/01/2022; b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022; b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, Expiration Date 08/01/2022
Distribution pattern
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
