Recall Z-1076-2010 ยท FPA Set, Administration, Intravascular
Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
| Date | Mar 30, 2010 (initiated Dec 18, 2009) |
| Status | Terminated |
| Reason | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. |
| Root cause | Process design |
| Action | A letter dated December 18, 2009 was sent to Acacia customers with the following instructions. 1. Immediately review your inventory of Acacia IV Extension Sets with BD Q-Syte for REF numbers and lot numbers listed and remove them from all inventory printed on the unit packaging , shelf box and shelf shipper containers. 2. Complete the Distributor Recall response Card (Attachment 1) and return by fax immediately to the number on the Distributor Recall Response Card for product in your facility at the time of receipt of this letter. This form must be completed and f axed to Acacia, Inc even |
| Quantity | 25,132 |
| Distribution | US Only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895367 | INTRAVENOUS EXTENSION SET Medical Product Specialists, Oct 6, 1989 |