RecallRadar

FDA Device recall Z-0691-2017

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

On 2016-12-07 the FDA classified a Class II recall of Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures by B Braun Medical, citing positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0691-2017
ClassificationClass II
Statusterminated
Initiated2016-07-29
Published2016-12-07
Last updated2026-09-13 11:54 UTC
CompanyB Braun Medical
DistributionUS

Product

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Reason

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

Identifiers

code_infoLot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0691-2017%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.