Recall Z-0197-2021 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case. UDI:(01)10887709088190(17)241201(30)50(10)4515232;(01)10887709068350(17)250101(30)50(10)4572761 The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f elect
| Date | Jul 6, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On July 6, 2020, the firm, icumedical, sent an "URGENT: MEDICAL DEVICE RECALL" notification of the market action to direct and indirect consignees of record via UPS. Stericycle, Inc. was contracted to send letters to consignees. The following is included in the "Required Actions for Users" section of the medical device recall notification: 1) Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the re |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100576 | HIGH PRESSURE SETS-400 PSI Icu Medical, Inc., Dec 17, 2010 |