Recall Z-0106-2018 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; 38" Non-DEHP Smallbore Ext Set w/2 T-
| Date | Nov 17, 2017 (initiated Aug 31, 2017) |
| Status | Terminated |
| Reason | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr. |
| Root cause | Manufacturing material removal |
| Action | ICU Medical, Inc. sent an Urgent Medical Device Recall Notification dated August 31, 2017. Customers will be instructed to quarantine any devices and return to ICU. Recipients will be instructed to continue the recall through to the end user of the device. Please call Customer Service, Monday through Friday between the hours of 7 am through 4:30pm CST @ 877-946-7747 and select option 9, or e-mail the following address: Productreturns@icumed.com |
| Quantity | 24,475 (17,225 in US) |
| Distribution | US Distribution and Internationally to TH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |