FDA Medical Device Recalls (openFDA)
Kendall Healthcare Products Co: Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730
- Recall number
- Z-0381-04
- Recalling firm
- Kendall Healthcare Products Co
- Product
- Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730
- Status
- Terminated
- Initiated
- 2004-01-08
- Posted
- 2004-07-20
- Terminated
- 2012-05-15
- Reason
- Sterility compromised due to lack of package seal integrity
- Root cause
- Other
- Action
- Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
- Quantity
- 188 cases
- Distribution
- AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
- Lot, serial or model codes
- Lot Numbers: 33462700 33462701 33462702 33462703 33472700 33472701
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAD
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- 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