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

FDA device recall Z-1083-2009 · posted 2009-03-16 · Terminated

Recall details

Recalling firm

Rochester Medical Corp

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.

Action taken

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

Status

Terminated

Product code

KOD

Quantity affected

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.

Date initiated

2009-01-14

Date posted

2009-03-16

Date terminated

2011-04-20

Location

Stewartville, MN

Related 510(k) clearances