Food, drugs, devices › Davol, Inc., Subs. C. R. Bard, Inc.
Device recall: Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies,
Davol, Inc., Subs. C. R. Bard, Inc. (Warwick, RI) initiated this device recall on 24 Apr 2014; FDA lists 15 product records under event 68124, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 23 Dec 2015. Initiation: voluntary: firm initiated. Davol, Inc., Subs. C. R. Bard, Inc. has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Davol, Inc., Subs. C. R. Bard, Inc., Warwick, RI.
Reason for recall
"Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal."
Distribution
"Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1682-2014 | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1683-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1684-2014 | Composix" LP with Echo PS" 6 x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1685-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1686-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1687-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1688-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1689-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1690-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1691-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1692-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1693-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1694-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1695-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
| Z-1696-2014 | 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. | — | Class II | Terminated | 11 Jun 2014 |
Context
Other enforcement events for Davol, Inc., Subs. C. R. Bard, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Oct 2014 | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists | Device | Class II | 1 |
| 3 Jan 2014 | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non- | Device | Class II | 2 |
| 4 Sep 2012 | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a | Device | Class II | 2 |
All 4 events for Davol, Inc., Subs. C. R. Bard, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.