Z-1083-2009

Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical...

Name: Z-1083-2009 Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical...
Creator: Rochester Medical Corp
Published: 2009-01-14
License: https://open.fda.gov/license/

Rochester Medical Corp. / initiated 2009-01-14 / Terminated / root cause: packaging

FDA source

Rochester Medical Corp began a recall of Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976... on 2009-01-14. The reason FDA records is "Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1083-2009
Status: Terminated
Initiated: 2009-01-14
Posted: 2009-03-16
Terminated: 2011-04-20
Recalling firm: Rochester Medical Corp.
Product: Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
Product code: KOD Catheter, Urological
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees 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 commerce: 6
Distribution: Worldwide 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.
Product codes and lots: lot # 53606910

Product code KOD

K000723Class IIHydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)Rochester Medical Corp. / cleared 2000-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)