RecallRadar

FDA Device recall Z-1469-2015

4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

On 2015-04-29 the FDA classified a Class II recall of 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids by Churchill Medical Systems, citing potential for leaking caused by insufficient bond between needleless device and female luer.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1469-2015
ClassificationClass II
Statusterminated
Initiated2015-01-15
Published2015-04-29
Last updated2026-09-13 11:53 UTC
CompanyChurchill Medical Systems
DistributionUS

Product

4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

Reason

Potential for leaking caused by insufficient bond between needleless device and female luer.

Identifiers

code_info1303123 1305003 1305008 1305049 1306097

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-1469-2015%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.