Z-0691-2017Class II

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

Name: Z-0691-2017 Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Creator: B. Braun Medical, Inc.
Published: 2016-07-29
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2016-07-29 / Terminated / root cause: sterility

FDA source

B. Braun Medical, Inc. began a recall of Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures on 2016-07-29. FDA classified it as Class II and gives the reason as "Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0691-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Posted: 2018-02-28
Terminated: 2018-03-06
Recalling firm: B Braun Medical Inc
Product: Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Product code: LRS I.V. Start Kit
Reason for recall: Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: BBMI (B. Braun) provided written notification on August 05, 2016, to all BBMI customers in receipt of the suspected product. These customers included both BBMI direct end customers and BBMI direct distributors. Customers were asked to determine if they had the affected lots in their possession. If they did, customers were asked not to destroy the product and to immediately discontinue use of and quarantine if found. Customers were also asked to complete the Product Removal Acknowledgement form and return to B. Braun. B. Braun will contact each customer if they have any full cases, partial cases or unused pieces of the affected products to provide instructions for handling and return of the affected products. Customers with questions were instructed to call 1-800-227-2862.
Quantity in commerce: 15,950 units
Distribution: Nationwide Distribution to GA, IL, and FL
Product codes and lots: Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0691-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0691-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)