Recall Z-2179-2012 ยท FPA Set, Administration, Intravascular
Medical Specialties Distributors, Inc.
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
| Date | Aug 9, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | Devices leaking at the Y-site |
| 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 th |
| Quantity | 472 cases (50/case) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090012 | DISPOSABLE INFUSION SET Shan Dong Wei Gao Group Medical Polymer Products, Jun 11, 2009 |