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DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A… recallZ-0863-2009 · Sunrise Medical · initiated Oct 27, 2008

Terminated All recalls posted in February 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sunrise Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Improper suction: Regulator knob does not turn properly which can affect the suction level.

FDA root cause category: Device Design

What the company is doing

DeVilbiss notified dealers and users (through the dealers) to recall the units, by a telephone call October 27, 2008 followed by an Urgent Medical Device Recall mailing November 3, 2008. The letter advised customers what models are affected and how to contact the firm of dealer to have the affected unit replaced. Corrective and preventative action on current manufacturing has been implemented.

Recall details

Recall number
Z-0863-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 27, 2008
Posted by the FDA
Feb 10, 2009
Recalling firm
Sunrise Medical
Quantity
78 units
Product code
JCX
FDA submissions
K982304
Distribution
Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.

Product description

DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model number 7310PR-D. Serial numbers PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000

Other devices under the same FDA submission

8 devices cleared under K982304 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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