Z-2226-2008

Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product...

Name: Z-2226-2008 Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product...
Creator: Gyrus ACMI Corporation
Published: 2008-06-25
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2008-06-25 / Terminated / root cause: manufacturing process

FDA source

Gyrus ACMI Corporation began a recall of Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation... on 2008-06-25. The reason FDA records is "Particulate matter in the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2226-2008
Status: Terminated
Initiated: 2008-06-25
Posted: 2008-09-16
Terminated: 2012-05-07
Recalling firm: Gyrus ACMI, Inc.
Product: Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter.
Product code: EYB Catheter, Ureteral, Gastro-Urology
Reason for recall: Particulate matter in the catheter
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Gyrus initiated a recall by letter dated 6/ 25 /08. An updated letter issued July 9, 2008 which supersedes the previous letter. The July 9th letter updates the lot numbers affected in the recall. A reply form request was sent to consignees informing them of the problem and asking them to obtain a RMA and return the product. They are also requested to FAX back a reply form so that the response can be tracked. For assistance, please contact Gyrus ACMI at 1-888-524-7266.
Quantity in commerce: 6820 units
Distribution: Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey
Product codes and lots: Lot Numbers: 7124026,7131020,7138014, 7152018,7158015,7169005,7201018,721 1016,72I404l, 7227021,7232046,7253048, 7256034,7263052,7269089,7276035,7277024,7284042,7291034,7296052,7303068, 7306089,7312076,7324062,7337052,7344047,7347078,7354102,7361043,8010043, 8017047,8025006, 8031030, 8036057, 8045050, 8052064, 8059055, 8066067, and 8073030

Product code EYB

K043581Class IIDual Lumen CatheterAcmi Corporation / cleared 2005-03-03

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)