Reported May 14, 2014 · Terminated

TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray).…

Tenex Health Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tenex Health Inc · 26902 Vista Terrance · Lake Forest, CA · 92630

Is this the product you have?

TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

Lot codes and dates: Lot Numbers
102 of 102 codes
00614-03
06513-02
24913-01
00713-06
06514-02
25313-01
00814-02
06914-01
25513-02
01114-02
07213-04
25613-01
01514-03
07713-18
26113-06
01714-04
08113-04
26313-04
01813-02
08413-13
26713-04
02314-08
09313-05
26813-01
02413-04
10213-07
27013-10
02714-02
10613-01
27613-02
02914-01
11213-07
28013-05
03014-02
11613-06
28313-02
03113-02
12113-02
29513-03
03114-02
12713-03
29713-01
03414-03
13413-01
30913-07
03514-05
14413-05
31113-08
03714-03
15013-04
31513-02
03814-06
15413-02
31713-05
04114-02
15413-03
32213-01
04213-01
16513-04
32413-01
Amount recalled: 9,927 units

Where it was sold

Nationwide

Why it was recalled

The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.

This product could cause temporary or reversible health problems — stop using it.

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