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 9
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3172948, 3192947, 3224228, 3246765, 3260270. Item No. 011-AM6111
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 2 of 9
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3297341, 3354442, 3388890. Item No. 011-AM6115
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 3 of 9
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3303906. Item No. 011-AM6116
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 4 of 9
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3296247. Item No. 011-AM6117
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 5 of 9
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3316827. Item No. 011-AM6118
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 6 of 9
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3320753. Item No. 011-AM6123
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 7 of 9
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 8 of 9
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Code information
Lot No. 3182596, 3204086, 3246762, 3263682, 3295482. Item No. AM6109
Distribution pattern
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
device · product 9 of 9
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
