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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68124
Product Type Devices
Status Ongoing
Recalling Firm Davol, Inc., Subs. C. R. Bard, Inc.
City Warwick
State RI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Bard® Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0691, HUXL0336, HUXL0495, HUXL0660, HUXL1006, HUXL1007, HUXL 1147 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1696-2014
Bard® Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0058 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1695-2014
Bard® Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0899 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1694-2014
Bard® Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0688, HUXK0743, HUXL0803, HUXL0804 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1693-2014
Bard® Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0744, HUXL1004 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1692-2014
Bard® Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0694, HUXL1149, HUXL1150, HUYA1005 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1691-2014
Bard® Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0695 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1690-2014
Bard® Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXH0535, HUXH0696, HUXK0747 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1689-2014
Bard® Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUYA1057 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1688-2014
Bard®Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0900, HUXK0901, HUXL1148 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1687-2014
Bard® Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1540 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1686-2014
Bard® Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1539 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1685-2014
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK0073, HUXK1537 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1684-2014
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. Lot Number: HUXK1536 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1683-2014
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. HUXH0294, HUXL0314 Class II Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Z-1682-2014
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