RecallRadar

FDA Device recall Z-0109-2014

Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic

On 2013-11-06 the FDA classified a Class II recall of Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic by Baxter Healthcare, citing potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0109-2014
ClassificationClass II
Statusterminated
Initiated2013-08-30
Published2013-11-06
Last updated2026-09-13 11:53 UTC
CompanyBaxter Healthcare
DistributionUS

Product

Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

Reason

Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471

Identifiers

code_infoR13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.