Recall Z-0365-2020 ยท FMF Syringe, Piston
Cadence Science, Inc.
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
| Date | May 10, 2019 |
| Status | Terminated |
| Reason | The glass syringe used with Pressure Control Syringes may potentially break during use. |
| Root cause | Under Investigation by firm |
| Action | On May 10, 2019, the firm distributed Advisory Notice letters to affected customers. Customers were advised of the potential issue involving breakage of the glass syringe used with Pressure Control Syringes. The firm recommended that the customer inspect the product for this issue prior to use in accordance with the Instructions For Use (IFU) which were provided with the product. The firm provided an additional IFU with the notification. Upon successful inspection, the firm recommended that customers continue to use the product in accordance with the IFU and continue to follow all OSHA recomm |
| Quantity | 237 |
| Distribution | US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.