Z-0606-2016Class II

Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s

Name: Z-0606-2016 Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s
Creator: Baxter Healthcare Corp.
Published: 2015-11-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-11-30 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of... on 2015-11-30. FDA classified it as Class II and gives the reason as "Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0606-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Posted: 2016-01-07
Terminated: 2016-10-30
Recalling firm: Baxter Healthcare Corporation
Product: Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
FDA root cause: Under Investigation by firm
Action: Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.
Quantity in commerce: 9600 units
Distribution: US Nationwide Distribution and the country of Canada
Product codes and lots: Lot Numbers: GR324012, GR325322, GR326769, and GF328518

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0606-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0605-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06
Z-0606-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06
Z-0607-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code FPA

K860272Class IISolution Administration SetsTravenol Laboratories, S.A. / cleared 1986-03-18

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)