FDA Medical Device Recalls (openFDA)
Gyrus ACMI Corporation: 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.
- Recall number
- Z-2226-2008
- Recalling firm
- Gyrus ACMI Corporation
- 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.
- Status
- Terminated
- Initiated
- 2008-06-25
- Posted
- 2008-09-16
- Terminated
- 2012-05-07
- Reason
- Particulate matter in the catheter
- 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
- 6820 units
- Distribution
- Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K043581"]
- PMA numbers
- not on file
- Product code
- EYB
- Firm FEI
- 3003790304
- Firm city
- Southborough
- 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