Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are

FDA device recall Z-2732-2015 · posted 2015-09-03 · Terminated

Recall details

Recalling firm

C.R. Bard, Inc.

Reason for recall

Potential breach of the sterile barrier packaging.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

KOD

Quantity affected

8,970 each

Distribution

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

Date initiated

2015-08-24

Date posted

2015-09-03

Date terminated

2016-08-01

Location

Covington, GA

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