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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Gyrus Acmi Corporation
- Recall Initiated
- June 25, 2008
- Posted
- September 16, 2008
- Terminated
- May 7, 2012
- Recall Number
- Z-2226-2008
- Quantity
- 6820 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Particulate matter in the catheter
Distribution
Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.