Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small… recallZ-1078-2010 · Medical Product Specialist Inc dba MPS Acacia · initiated Dec 18, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Product Specialist Inc dba MPS Acacia or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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 if there is no product in inventory. 3. Acacia, Inc is currently working to ensure that replacement products are readily available. Once you have identified how much product you will be returning, please call your Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, to arrange for product replacement. Questions are to be directed to the Customer Representative at 1-800-453-4538, opt. 2, ext. 2534, between 8:00AM and 5:00PM MST, Monday-Friday.
Recall details
- Recall number
- Z-1078-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 18, 2009
- Posted by the FDA
- Mar 30, 2010
- Recalling firm
- Medical Product Specialist Inc dba MPS Acacia
- Quantity
- 6,936
- Product code
- FPA
- FDA submissions
- K895367
- Distribution
- US Only
Product description
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Code information (models, lots, serial numbers)
Lot A1951
Other devices under the same FDA submission
1 device cleared under K895367 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Enteral Feeding ENF060182LDMedela LLC · Set, Administration, Intravascular1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 54181).
- Z-1076-2010 · TerminatedAcacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
- Z-1077-2010 · TerminatedAcacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
- Z-1079-2010 · TerminatedAcacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
- Z-1080-2010 · TerminatedAcacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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