Recall Z-1081-2009 ยท KOD Catheter, Urological
Rochester Medical Corp
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
| Date | Mar 16, 2009 (initiated Jan 14, 2009) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 43 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) Rochester Medical Corp., May 19, 2000 |