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U.S. Department of Health and Human Services

Class 2 Device Recall Large Volume Paracentesis Kit

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  Class 2 Device Recall Large Volume Paracentesis Kit see related information
Date Initiated by Firm January 28, 2016
Create Date March 04, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall Number Z-1047-2016
Recall Event ID 73151
510(K)Number K970187  
Product Classification General surgery tray (kit) - Product Code LRO
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
Code Information Lot #: 61442434 Expiration Date: 2018/04
Recalling Firm/
Manufacturer		 Gi Supply
200 Grandview Ave
Camp Hill PA 17011-1706
For Additional Information Contact Customer Service
800-451-9894
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The customers will be made aware of the defect, including pictures provided and are instructed to inspect the RP Bags in the kit prior to use. If the pinch clamp is missing, the customer is instructed to discard the RP Bag and use the sterile RP Bag replacements provided.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = GI SUPPLY
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