FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
- Recall number
- Z-0691-2017
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
- Status
- Terminated
- Initiated
- 2016-07-29
- Posted
- not on file
- Terminated
- 2018-03-06
- Reason
- Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
- 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
- 15,950 units
- Distribution
- Nationwide Distribution to GA, IL, and FL
- Lot, serial or model codes
- Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28