Z-0811-06

MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is...

Name: Z-0811-06 MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is...
Creator: Medex Inc
Published: 2005-11-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-11-18 / Terminated / root cause: labeling and UDI

FDA source

Medex Inc began a recall of MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The... on 2005-11-18. The reason FDA records is "The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0811-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2006-04-26
Terminated: 2008-01-22
Recalling firm: Abbott Medical
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''
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.
Root cause tag: labeling and UDI
FDA 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 in commerce: 2480 devices
Distribution: The recalled device was distributed to a single direct account customer located in Alabama and to
Product codes and lots: 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

Product code GWM

K822864Class IIIntracranial Pressure Monitoring DeviceMedex, Inc. / cleared 1982-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)