Z-1277-2015Class II

Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year...

Name: Z-1277-2015 Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year...
Creator: US Infusion Inc dba Trucare Biomedix-USA
Published: 2014-10-10
License: https://open.fda.gov/license/

US Infusion LLC. D/B/a Truecare Biomedix-USA / initiated 2014-10-10 / Terminated

FDA source

US Infusion Inc dba Trucare Biomedix-USA began a recall of Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date on 2014-10-10. FDA classified it as Class II and gives the reason as "Several complaints regarding the IV sets leaking at the Y site". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1277-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Posted: 2015-03-13
Terminated: 2015-06-23
Recalling firm: US Infusion LLC. D/B/a Truecare Biomedix-USA
Product: Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Several complaints regarding the IV sets leaking at the Y site.
FDA 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 [email protected].
Quantity in commerce: 62,700 IV sets
Distribution: Distributed in the states of TX, IL, MA, OH, CA, and GA.
Product codes and lots: Model # MS721, Lot # 20111115.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1277-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-13

Product code FPA

K090012Class IIDisposable Infusion SetShan Dong Wei Gao Group Medical Polymer Products / cleared 2009-06-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)