Atlas FDA

Rhinocell Nasal 6.0 x 1.5 x 2.0 w/Airway Catalog #: BMPNP601520A

FDA device recall Z-0486-03 · posted 2003-01-30 · Terminated

Recall details

Recalling firm
Ultracell Medical Technologies
Reason for recall
Sterility of the device is compromised
Action taken
Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
Root cause
Other
Status
Terminated
Product code
EMX
Quantity affected
100 units
Distribution
Nationwide
Date initiated
2003-01-08
Date posted
2003-01-30
Date terminated
2012-05-01
Location
North Stonington, CT

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Related 510(k) clearances

RecordFirmDate
ULTRACELL NASAL PACKING (K920358)Ultracell Medical Technologies, Inc.1992-11-30