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Terminated

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

FDA Recall Z-1277-2015 · Posted 2015-03-13

Recalling FirmUS Infusion Inc dba Trucare Biomedix-USA
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-10-10
Date Terminated2015-06-23
Product Quantity62,700 IV sets

Reason for Recall

Several complaints regarding the IV sets leaking at the Y site.

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].

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Distributed in the states of TX, IL, MA, OH, CA, and GA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090012DISPOSABLE INFUSION SETShan Dong Wei Gao Group Medical Polymer Products · 2009-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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