Recall Z-2364-2015 ยท GAA Needle, Aspiration And Injection, Disposable
Cadence Inc.
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
| Date | Aug 10, 2015 (initiated Jul 9, 2015) |
| Status | Terminated |
| Reason | Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. |
| Root cause | Device Design |
| Action | Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031 |
| Quantity | 766 units |
| Distribution | Nationwide Foreign Canada, Denmark. Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.