Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes);
FDA device recall Z-0103-2012 · posted 2011-10-21 · Terminated
Recall details
- Recalling firm
- Hamilton Co
- Reason for recall
- Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".
- Action taken
- The firm, Hamilton, sent an "Urgent: Product Recall Notification" letter dated September 26, 2011 to its customers. The letter describes the product, problem and action to be taken. The customers were instructed to return the syringes with a completed Hamilton Company Product Recall Questionnaire form via fax to: (775) 856-7259 or with an emailed signed pdf copy to wayne.mcauliffe@hamiltoncompany.com. The firm's Customer Service Department will contact customers with complete Returned Material Authorization information. If you have any questions, please do not hesitate to contact the Director of Quality at (775) 858-3000.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1096 units
- Distribution
- Worldwide distribution: USA(nationwide) including states of: NJ, NV, TX and WA; and countries of: Brazil, P.R. China, France and Germany.
- Date initiated
- 2011-09-26
- Date posted
- 2011-10-21
- Date terminated
- 2012-03-06
- Location
- Reno, NV
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER (K943493) | Hamilton Co. | 1995-01-30 |