All Med Medical 19ga x .75" RA Hub Needle Model #M1975H Reorder #55-1920 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
FDA Recall Z-2535-2010 · Posted 2010-09-29
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Recalling FirmMulti-Med, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2010-08-30
Date Terminated2013-01-31
Product Quantity4,012 units
Reason for Recall
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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