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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 Kitsee related information
Date Initiated by FirmJanuary 28, 2016
Create DateMarch 04, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall NumberZ-1047-2016
Recall Event ID 73151
510(K)NumberK970187 
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 ContactCustomer 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
ActionThe 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 Commerce390 Kits
DistributionDistributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LRO
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