FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
- Recall number
- Z-0623-2013
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
- Status
- Terminated
- Initiated
- 2012-03-23
- Posted
- 2012-12-31
- Terminated
- 2015-02-02
- Reason
- Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
- Root cause
- Device Design
- Action
- B. Braun Medical, Inc sent an Urgent Medical Device letter dated March 23, 2012 , to all affected customers. The letter identified the product the problem and the action needed by the customer to take. B. Braun has implemented an improvement to the pump locking mechanism of t he older style pole clamps and will be upgrading any older style pole clamps that may remain within your facility. Please return the completed form from attachment 1 in the self-addressed envelope provided or fax the form to (610) 849-1197 within two (2) weeks of receipt\. If you require any additional information or have any questions, comments or concerns please contact your B. Braun Medical Customer Service at 800-627-7867.
- Quantity
- 13,078
- Distribution
- Worldwide Distribution--US (nationwide) including the states of AL, AZ, NC and TN.
- Lot, serial or model codes
- Model number 8713130 and lot numbers 209, 309, 409, 509, 809, 909, 60939747, 60943679, 60945966, 60948966, 60959578, 60960830, 60962412, 61170378, 5048020067, 5048805107, 5048920117, 5049152127, 5049484028, 5049545028, 5049614028, 5049704038, 5049788048, 5049821048, 5050123058, 5050297068, 5050385078, 5051802039, 5051879039, 5051893059, 5051940049, 5051999049, 5052519099, 5052638099, 5052690109, 5052692109, 5052711109, 5052726119, 5052788119, 5052920119, 5053045129, 5053112010, 5053129129, 5053146010, 5053207010, 5053269020, 5053449020, 5053505030, 5053534040, 5053584030, 5053605040, and 5053645040.
- 510(k) numbers
- ["K062700","K083689"]
- PMA numbers
- not on file
- Product code
- FRN
- 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