Z-1078-2010

Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte

Name: Z-1078-2010 Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Creator: Medical Product Specialist Inc dba MPS Acacia
Published: 2009-12-18
License: https://open.fda.gov/license/

Medela AG / initiated 2009-12-18 / Terminated / root cause: manufacturing process

FDA source

Medical Product Specialist Inc dba MPS Acacia began a recall of Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte on 2009-12-18. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1078-2010
Status: Terminated
Initiated: 2009-12-18
Posted: 2010-03-30
Terminated: 2011-01-05
Recalling firm: Medela AG
Product: Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 6,936
Distribution: US Only
Product codes and lots: Lot A1951

Product code FPA

K895367Class IIIntravenous Extension SetMedical Product Specialists / cleared 1989-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)