Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
FDA device recall Z-1277-2015 · posted 2015-03-13 · Terminated
Recall details
- Recalling firm
- US Infusion Inc dba Trucare Biomedix-USA
- Reason for recall
- Several complaints regarding the IV sets leaking at the Y site.
- Action taken
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 62,700 IV sets
- Distribution
- Distributed in the states of TX, IL, MA, OH, CA, and GA.
- Date initiated
- 2014-10-10
- Date posted
- 2015-03-13
- Date terminated
- 2015-06-23
- Location
- South Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE INFUSION SET (K090012) | Shan Dong Wei Gao Group Medical Polymer Products | 2009-06-11 |