FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in
- Recall number
- Z-0700-2010
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in
- Status
- Terminated
- Initiated
- 2009-11-24
- Posted
- 2010-01-26
- Terminated
- 2011-02-14
- Reason
- System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.
- Quantity
- 7872 units
- Distribution
- The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
- Lot, serial or model codes
- Product Code NF3106. Lot number 61020609 exp 3/31/2009
- 510(k) numbers
- ["K931377"]
- PMA numbers
- not on file
- Product code
- FPA
- 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