Recall Z-2111-2018 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It in
| Date | Nov 6, 2017 |
| Status | Terminated |
| Reason | Reports of incorrect priming volume due to manufacturing with incorrect tubing. |
| Root cause | Under Investigation by firm |
| Action | The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support C |
| Quantity | 25,400 units |
| Distribution | US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA |
| FDA record | Open on fda.gov |