Recall Z-0189-2007 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Eatonform Inc
Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton.
| Date | Nov 16, 2006 (initiated Sep 28, 2006) |
| Status | Terminated |
| Reason | The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers. |
| Root cause | Other |
| Action | The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 9/28/2006. In their recall notification, the firm requests that the customers: 1) Cease using and distributing all Doc-U-Dose packets identified with the recalled carton numbers [instructions are provided as to how to identify the carton number]; 2) Segregate and secure all Doc-U-Dose packets identified with the suspect carton numbers [16 - 39 inclusive] or any packets from open cartons bearing those numbers; 3) Complete the attached Recall Verification Form which requests info |
| Quantity | 24 cartons [24,000 sets of four packets each] |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.