Data Foundry

Medical device recalls 2013

A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set — Class II medical device recall Z-1269-2013

Terminated recall by Baxter Healthcare Corp., reported 2013-05-15, distributed nationwide. Customers have reported that when separating an individual package from its attached grouping, the adjacent pa

Recall numberZ-1269-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corp., Deerfield, IL, United States
Recall initiated2013-03-28
Classified2013-05-07
Reported by FDA2013-05-15
Terminated2017-07-31
DistributedNationwide (US)
Countries outside the USBR, CA
Reason classessterility
Lot numbersR12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057

Product

A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1269-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.