PlainRecalls
FDA Devices Moderate Class II Terminated

9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into

Reported: October 28, 2020 Initiated: July 6, 2020 #Z-0209-2021

Product Description

9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

Reason for Recall

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
Total of all products (Listed #1 thru 101) = 304735 units
Distribution
Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled? ▼
9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).. Recalled by ICU Medical, Inc.. Units affected: Total of all products (Listed #1 thru 101) = 304735 units.
Why was this product recalled? ▼
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0209-2021.

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