Z-2525-2015Class II
Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129
Medtronic, Inc. / initiated 2015-08-06 / Terminated / root cause: packaging
Covidien LLC began a recall of Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous... on . FDA classified it as Class II and gives the reason as "Sterility may be compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2525-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- 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.
- Product code
- NGT Saline, Vascular Access Flush
- Reason for recall
- Sterility may be compromised
- Root cause tag
- packaging
- FDA root cause
- Packaging process control
- Action
- 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
- Quantity in commerce
- 207,876
- Distribution
- US Nationwide Distribution
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2525-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2526-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2527-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2528-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2529-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2530-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2531-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2532-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2533-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2534-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2535-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2536-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2537-2015 | Class II | Terminated | Voluntary: Firm initiated |
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