Z-2179-2012Class II

Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured...

Name: Z-2179-2012 Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured...
Creator: Medical Specialties Distributors, Inc.
Published: 2012-08-03
License: https://open.fda.gov/license/

Medical Specialties Distributors, Inc. / initiated 2012-08-03 / Terminated / root cause: manufacturing process

FDA source

Medical Specialties Distributors, Inc. began a recall of Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC... on 2012-08-03. FDA classified it as Class II and gives the reason as "Devices leaking at the Y-site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2179-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Posted: 2012-08-09
Terminated: 2015-01-23
Recalling firm: Medical Specialties Distributors, Inc.
Product: Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
Product code: FPA Set, Administration, Intravascular
Reason for recall: Devices leaking at the Y-site
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medical Specialties Distributors LLC sent an Urgent Medical Recall letter dated August 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and remove all affected product from use immediately. Further distribution of the affected product should be discontinued immediately. Customers were instructed to contact their customers and inform them of the recall; complete and return the acknowledgement form and fax to 781-344-8320 to arrange for a return and to contact the Customer Service Department at (800) 967-6400 with questions. For questions regarding this recall call 781-344-6000.
Quantity in commerce: 472 cases (50/case)
Distribution: Nationwide Distribution
Product codes and lots: LOT NUMBER: 20111115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2179-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2179-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)