Recall Z-0023-2015 ยท FPA Set, Administration, Intravascular
Biomedix, Inc.
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
| Date | Oct 6, 2014 (initiated Aug 14, 2014) |
| Status | Terminated |
| Reason | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure. |
| Root cause | Process control |
| Action | Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions. |
| Quantity | 2,928 |
| Distribution | US Distribution including the states of OH, NC, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142097 | SELEC-3 I.V.ADMINISTRATION SET Biomedix, Inc., Aug 29, 2014 |