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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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 Class 2 Device Recall Covidiensee related information
Date Initiated by FirmAugust 06, 2015
Date PostedSeptember 01, 2015
Recall Status1 Terminated 3 on June 29, 2017
Recall NumberZ-2525-2015
Recall Event ID 71893
510(K)NumberK060339 
Product Classification Saline, vascular access flush - Product Code NGT
ProductMonoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Code Information Lot Numbers: P15035 P15036 P15037 P15041 P15042 P15046 P15047 P15048 P15049 P15056 P15057 P15058 P15059 P15063 P15064 P15069 P15070 P15071 P15078 P15079 P15080 P15081 P15091            
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactSame
203-492-5000
Manufacturer Reason
for Recall		Sterility may be compromised
FDA Determined
Cause 2		Packaging process control
ActionMedtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
Quantity in Commerce207,876
DistributionUS Nationwide Distribution
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 = NGT
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