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U.S. Department of Health and Human Services

Class 2 Device Recall Magic3 Hydrophilic 6 French Pediatric

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 Class 2 Device Recall Magic3 Hydrophilic 6 French Pediatricsee related information
Date Initiated by FirmJanuary 14, 2009
Date PostedMarch 16, 2009
Recall Status1 Terminated 3 on April 20, 2011
Recall NumberZ-1077-2009
Recall Event ID 51205
510(K)NumberK000723 
Product Classification Urological Catheter - Product Code KOD
ProductMagic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
Code Information Lot # 53606896
FEI Number 2130787
Recalling Firm/
Manufacturer		 Rochester Medical Corp
1 Rochester Medical Dr Nw
Stewartville MN 55976-1647
For Additional Information Contact
507-533-4203
Manufacturer Reason
for Recall		Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
FDA Determined
Cause 2		Package design/selection
ActionConsignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
Quantity in Commerce149
DistributionWorldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KOD
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