FDA Medical Device Recalls (openFDA)
US Infusion Inc dba Trucare Biomedix-USA: Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
- Recall number
- Z-1277-2015
- Recalling firm
- US Infusion Inc dba Trucare Biomedix-USA
- Product
- Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
- Status
- Terminated
- Initiated
- 2014-10-10
- Posted
- 2015-03-13
- Terminated
- 2015-06-23
- Reason
- Several complaints regarding the IV sets leaking at the Y site.
- Root cause
- Unknown/Undetermined by firm
- Action
- On December 10, 2014 the firm sent an URGENT DRUG RECALL to its consignees. Instructions were to immediately examine inventory and quarantine all product subject to the recall. Customers were asked to complete and return the response form. For returned goods instructions contact Roberta Parness at 866-593-8444 or via email at rparness@tcbiomedix.com.
- Quantity
- 62,700 IV sets
- Distribution
- Distributed in the states of TX, IL, MA, OH, CA, and GA.
- Lot, serial or model codes
- Model # MS721, Lot # 20111115.
- 510(k) numbers
- ["K090012"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3008782867
- Firm city
- South Miami
- Firm state
- FL
- 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