Recall Z-1047-2016— Gi Supply
Class II · Terminated
Class II FDA medical device recall by Gi Supply, initiated 2016-01-28, terminated 2016-12-07. It names one FDA 510(k) clearance: K970187. 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..
- Recalling firm
- Gi Supply
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-28
- Terminated
- 2016-12-07
- Firm location
- Camp Hill, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.