Class II — Gi Supply
| Recalling firm | GI SUPPLY |
|---|---|
| Registered facility | GI SUPPLY (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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 |
| 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. |
| Initiated | 2016-01-28 |
| Classified | 2016-03-04 |
| Terminated | 2016-12-07 |
| Recall number | Z-1047-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Gi Supply (Z-1047-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73151/
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