Z-0132-2016Class II

One-Link Non-Dehp Y-Type Microbore Catheter Extension Set Needle-Free IV Connector with Neutral Fluid...

Name: Z-0132-2016 One-Link Non-Dehp Y-Type Microbore Catheter Extension Set Needle-Free IV Connector with Neutral Fluid...
Creator: Baxter Healthcare Corp
Published: 2015-05-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-05-21 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp began a recall of ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT on 2015-05-21. FDA classified it as Class II and gives the reason as "Potential for a leak at the tubing to luer bond". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0132-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-10-16
Terminated: 2017-05-10
Recalling firm: Baxter Healthcare Corporation
Product: One-Link Non-Dehp Y-Type Microbore Catheter Extension Set Needle-Free IV Connector with Neutral Fluid Displacement
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for a leak at the tubing to luer bond.
Root cause tag: packaging
FDA root cause: Packaging
Action: Baxter sent their consignees a recall letter dated 05/21/2015 with the following instructions: Actions to betaken if product was purchased directly from Baxter : 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected] . Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departm ents within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or Original Equipment Manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. Action to be taken if product was purchased from a distributor: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00pm central time, Monday through Friday. 3. Pl ease note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to the
Quantity in commerce: 23,600
Distribution: Domestic Only
Product codes and lots: Code: 7N8371, Lots: UR15B16021 and UR15B23043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0132-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-16

Product code FPA

K132734Class IINeutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp / cleared 2013-10-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)