Recall Z-0257-2021 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.
| 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 |
| Quantity | 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 Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974589 | SMARTVALVE Icu Medical, Inc., Jan 9, 1998 |