Z-2527-2010
All Med Medical 22ga x .75" Standard Bore Winged Administration Set Model # M2275S Reorder # 50-2223
Multi-Med, Inc. / initiated 2010-08-30 / Terminated / root cause: design
Multi-Med, Inc. began a recall of All Med Medical 22ga x .75" Standard Bore Winged Administration Set Model # M2275S Reorder # 50-2223 on . The reason FDA records is "Huber needles may core and result in port leakage or emboli being flushed our of the port". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2527-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Multi-Med, Inc.
- Product
- All Med Medical 22ga x .75" Standard Bore Winged Administration Set Model # M2275S Reorder # 50-2223
- Product code
- FMI Needle, Hypodermic, Single Lumen
- Reason for recall
- Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.
- Quantity in commerce
- 204 units
- Distribution
- Worldwide Distribution -- USA and Mexico.
- Product codes and lots
- Lot code: 8F002A
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