FDA Medical Device Recalls (openFDA)
Medex Inc: MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
- Recall number
- Z-0811-06
- Recalling firm
- Medex Inc
- Product
- MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
- Status
- Terminated
- Initiated
- 2005-11-18
- Posted
- 2006-04-26
- Terminated
- 2008-01-22
- 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 telephone the firm and obtain a Return Authorization number in order to return the recalled product.
- Quantity
- 2480 devices
- Distribution
- The recalled device was distributed to a single direct account customer located in Alabama and to
- Lot, serial or model codes
- All Lot codes listed as follows are affected: 30K200116, 31A160060, 31A250027, 31B280077, 31E160051,31H030002, 31I140023, 31J050052,31J250065, 32C070041, 32I050037, 32K250019, 33A300046, 33C170028, 33E290076, 33H220008, 3L170057, 34B16D038, 34B26D062, 34E05D055, 34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021, 34L16D040
- 510(k) numbers
- ["K822864"]
- PMA numbers
- not on file
- Product code
- GWM
- 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