Recall Z-0155-2022 ยท FMG Stopcock, I.V. Set
Smiths Medical ASD Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE
| Date | May 10, 2018 |
| Status | Terminated |
| Reason | Product has a lack of sterility assurance |
| Root cause | Package design/selection |
| Action | The firm, Smiths Medical, notified their consignees of the recall by issuing an "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" dated 3/2018 on 05/10/2018. The notice described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: PLEASE TAKE THE FOLLOWING ACTIONS TO HELP US PROPERLY EXECUTE THIS FIELD SAFETY CORRECTIVE ACTION: 1. Identify any affected Infusion Stopcocks in your possession 2. Determine the number of affected products in your possession and complete the Field Safety Notice (FSN) Response Form attached to this letter within |
| Quantity | 933,518 units |
| Distribution | International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS Elcam Medical Acal, Jul 30, 2014 |