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

FDA device recall Z-2179-2012 · posted 2012-08-09 · Terminated

Recall details

Recalling firm

Medical Specialties Distributors, Inc.

Reason for recall

Devices leaking at the Y-site

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FPA

Quantity affected

472 cases (50/case)

Distribution

Nationwide Distribution

Date initiated

2012-08-03

Date posted

2012-08-09

Date terminated

2015-01-23

Location

Stoughton, MA

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