Large Volume Paracentesis Kit is packaged in a thermaformed tray… — Class II medical device recall Z-1047-2016
Terminated recall by Gi Supply, reported 2016-03-16, distributed in CA, DC, FL, IA, KY, MA, MO, NH…. Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavit
| Recall number | Z-1047-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gi Supply, Camp Hill, PA, United States |
| Recall initiated | 2016-01-28 |
| Classified | 2016-03-04 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-12-07 |
| Distributed | CA, DC, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, TN |
| Quantity | 390 kits |
| Lot numbers | 2018/04, 61442434 |
| Model numbers | GIS-28 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1047-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.