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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus ACMI 10 Fr. Dual Lumen Catheter

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  Class 2 Device Recall Gyrus ACMI 10 Fr. Dual Lumen Catheter see related information
Date Initiated by Firm June 25, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-2226-2008
Recall Event ID 48691
510(K)Number K043581  
Product Classification Catheter - Product Code EYB
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.
Code Information 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   
Recalling Firm/
Manufacturer		 Gyrus ACMI Corporation
136 Turnpike Rd
Southborough MA 01772-2118
For Additional Information Contact SAME
763-416-3000
Manufacturer Reason
for Recall		 Particulate matter in the catheter
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EYB and Original Applicant = ACMI CORPORATION
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