Recall Z-1047-2016 ยท LRO General Surgery Tray
Gi Supply
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
| Date | Jan 28, 2016 |
| Status | Terminated |
| Reason | Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal. |
| Root cause | Nonconforming Material/Component |
| Action | The customers will be made aware of the defect, including pictures provided and are instructed to inspect the RP Bags in the kit prior to use. If the pinch clamp is missing, the customer is instructed to discard the RP Bag and use the sterile RP Bag replacements provided. |
| Quantity | 390 Kits |
| Distribution | Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT Gi Supply, Feb 14, 1997 |