FDA Device recall Z-1047-2016
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components by Gi Supply, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1047-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-28 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Gi Supply |
| Distribution | CA, DC, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, TN |
Product
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
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.
Identifiers
| code_info | Lot #: 61442434 Expiration Date: 2018/04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2016%22
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