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U.S. Department of Health and Human Services

Class 2 Device Recall Situate Gauze

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 Class 2 Device Recall Situate Gauzesee related information
Date Initiated by FirmOctober 12, 2017
Create DateMarch 19, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-1130-2018
Recall Event ID 79296
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
ProductSituate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.
Code Information Lot Number: 170704A UDI: 20884521700861
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall		This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAll consignees were notified via FedEx or certified mail on October 12, 2017 and the letter 'Urgent Field Corrective action Notice' informs customers of the potential for failure to detect the affected Situate" gauze RF and X-Ray detectable products by the Situate" detection console and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Correction Action Notice. For further questions, please call (203) 492-5000.
Quantity in Commerce20,800
DistributionU.S.
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.
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