FDA Medical Device Recalls (openFDA)
Medex Inc: MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''
- Recall number
- Z-0812-06
- Recalling firm
- Medex Inc
- Product
- MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''
- Status
- Terminated
- Initiated
- 2005-11-18
- Posted
- 2006-04-26
- Terminated
- 2007-05-07
- Reason
- The product is labeled as 'Latex Free' , however,one of the components of the finished product may contain latex.
- Root cause
- Other
- Action
- The firm sent a recall letter dated 11/18/2005, via Certified mail to all of their customers. In the letter, the firm requests that the consignee(s) telephone the firm and obtain a Return Authorization number in order to return the recalled product.
- Quantity
- 6910 devices
- Distribution
- The recalled device was distributed to customers throughout the U.S.A. and in Canada.
- Lot, serial or model codes
- All of the following lot codes are affected: Lot Numbers: 30J030048, 30K150054, 31A030144, 31b120110, 31B355998, 31C190086, 31c260053, 31D300042, 31F80073, 31I240006, 31J220068, 32C250072, 32H050182, 32K050108, 33f030089, 33G210028, 33J270026, 34C01D100, 34G01D063, 35A04D101, 35A31D040, 35C29D125
- 510(k) numbers
- ["K904674"]
- PMA numbers
- not on file
- Product code
- KRK
- Firm FEI
- 1526863
- Firm city
- Dublin
- Firm state
- OH
- 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