Z-1047-2016 Class II Terminated
FDA device recall Z-1047-2016 was initiated by Gi Supply on January 28, 2016 and is designated Class II. 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. The recall status is terminated (terminated December 7, 2016). Affected quantity: 390 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2016
- Initiation Date
- January 28, 2016
- Termination Date
- December 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390 Kits
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.
Distribution Pattern
Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
Code Information
Lot #: 61442434 Expiration Date: 2018/04