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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Gyrus ACMI Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Gyrus ACMI Corporation is recalling Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) Thi due to Particulate matter in the catheter. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Particulate matter in the catheter
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026