—#139286

Product

Monoject 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.

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060339
Affected lot / code info: 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

Why it was recalled

Sterility may be compromised

Root cause (FDA determination)

Packaging process control

Action the firm took

Medtronic/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

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2015-08-06
Posted by FDA: 2015-09-01
Terminated: 2017-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139286. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.