Recall Z-1968-2020 ยท FPA Set, Administration, Intravascular
BD SWITZERLAND SARL
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Direction
| Date | Apr 9, 2020 |
| Status | Terminated |
| Reason | The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication. |
| Root cause | Under Investigation by firm |
| Action | URGENT MEDICAL DEVICE RECALL BD Alaris PCEA Administration Set and BD Alaris PCEA Administration Kit letters dated 4/9/20 were distributed to customers. Please Take the Following Actions: 1. Immediately review your inventory for the Catalog and Lot Numbers specified in this notification and discard all product subject to the recall. 2. Share this recall notification with any users of the product, within your facilities, to ensure they are also aware of this recall. 3. As a direct replacement will not be available for the foreseeable future, complete the attached Customer Response Form and ret |
| Quantity | 110,350 |
| Distribution | Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811885 | 30-30-2 700 SYRINGE EXTENSION SET Y, Aug 25, 1981 |