Recall Z-0189-2021— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-07-06, terminated 2023-05-11. It names one FDA 510(k) clearance: K964435. Product: 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 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: 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..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-06
- Terminated
- 2023-05-11
- Firm location
- San Clemente, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709052953(17)241201(30)50(10)4536611;(01)10887709052953(17)250101(30)50(10)4557492 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.