Davol, Inc., Sub. C. R. Bard, Inc.

Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005.  If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.

General and Plastic Surgery Devices

2

Yes

Nationwide Foreign: Australia, Canada, Japan,

Bard Composix Kugel Mesh X-Large Patch || Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) || Code: 0010208

Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****

General and Plastic Surgery Devices

2

Yes

Nationwide Foreign: Australia, Canada, Japan,

Bard¿ Composix¿ Kugel Large Circle, 4.5'' for hernia repairs || Product Code: 0010204

All Lot Numbers

General and Plastic Surgery Devices

2

Yes

Nationwide Foreign: Australia, Canada, Japan,

Bard¿ Composix¿ Kugel Oval, 6.3'' x 12.3'' for hernia repairs || Product Code: 0010209

All serial numbers

General and Plastic Surgery Devices

2

Yes

Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa.

Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. || Reference Number 0113037 or 9113037(refurbished)

Recalled Lot Numbers: 43AOD 43LOD  43BOD 43APD  43COD 43BPD  43DOD 43CPD  43EOD 43DPD  43FOD 43EPD  43GOD 43FPD  43HOD 43GPD  43IOD 43HPD 43JOD 43IPD  43KOD; Market Wthdrawal Lot Numbers: 43JPD 43DQD  43KPD 43EQD  43LPD 43FQD 43AQD 43GQD  43BQD 43HQD  43CQD 43IQD* *Redesigned products will be clearly indicated on the  label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.

General and Plastic Surgery Devices

2

Yes

Nationwide

Bard Composix Kugel Hernia Patch- || Large Oval with ePTFE , 5.4'' x 7.0'' || Product Number: 0010202