—#139591

Product

Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K000723
Affected lot / code info: Lot Number 53621456

Why it was recalled

Potential breach of the sterile barrier packaging.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

The firm, Bard, sent an "URGENT: MEDICAL PRODUCT RECALL" letter dated August 20, 2015 to customers via FedEx on 8/24/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to not use or further distribute any affected product; check inventory and remove any identified affected product from your shelves; complete and return the Recall and Effectiveness Check Form by September 19, 2015, even if you have used or no longer have possession of the affected product, via fax to 1-770-784-6469 or email a scanned copy to Regan.Gealy@crbard.com ( if you cannot fax or email the form, call 1-770-784-6471 and report the required information verbally); and if you have further distributed any units of the affected lot, identify your customers and notify them at once of this product recall, and return product to Bard Medical Division, 8195 Industrial Blvd., Covington, GA 30014. BMD will provide replacement product or credit for your return product. If you have any questions, please call Vice President, Quality Assurance at 770-784-6119.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

Distribution pattern: US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.

Timeline

Recall initiated: 2015-08-24
Posted by FDA: 2015-09-03
Terminated: 2016-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.