Z-1268-2013Class II

A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter...

Name: Z-1268-2013 A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter...
Creator: Baxter Healthcare Corp.
Published: 2013-03-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-03-28 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP... on 2013-03-28. FDA classified it as Class II and gives the reason as "Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties". 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-1268-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-05-07
Terminated: 2017-07-31
Recalling firm: Baxter Healthcare Corporation
Product: A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
Quantity in commerce: A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
Distribution: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Product codes and lots: A) Product Code 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1269-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1270-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07
Z-1271-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-07

Product code FPA

K811078Class IIRadiation Sterilized Admin. SetTravenol Laboratories, S.A. / cleared 1981-07-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)