FDA Medical Device Recalls (openFDA)
Ram Medical Inc: Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
- Recall number
- Z-1649-2010
- Recalling firm
- Ram Medical Inc
- Product
- Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-06-08
- Terminated
- 2016-06-06
- Reason
- Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.
- Root cause
- Nonconforming Material/Component
- Action
- Ram Medical Inc., contacted Customers by phone beginning March 4, 2010 and issued "Urgent Device Recall" notifications beginning March 8, 2010. Further notifications were issued to expand the scope of the recall by the firm. Each notification described the affected product and asked the User to complete a Recall Acknowledgement Form and return it to the firm. All affected product should be returned to the firm. For further information, contact Ram Medical, Inc. at 1-973-633-0400 Monday through Friday, 9:00 AM to 5:00 PM EST.
- Quantity
- 135 boxes of lor 43HPD027, 25 boxes of 43HPD032; 42 boxes of HUSG0540
- Distribution
- Nationwide Distribution -- CO, IL , NY, MO and FL.
- Lot, serial or model codes
- Item Code: 0112680, Lot Numbers: 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43HPD034.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 1000222355
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28