ICU Medical, Inc. Recall: 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 Mi
ICU Medical, Inc. Recall: 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 Mi is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: ICU Medical, Inc.; Product: 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve
| Recalling firm | ICU Medical, Inc. |
|---|---|
| Product | 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709079127(17)250201(30)25(10)4727501. 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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 Sa |
| Recall initiated | 20200706 |
| Recall number | Z-0258-2021 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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