Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall Z-1074-2009 · Posted 2009-03-16
Advertisement
Recalling FirmRochester Medical Corp
Recall StatusTerminated
Product CodeKOD
Date Initiated2009-01-14
Date Terminated2011-04-20
Product Quantity12
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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement