Home / Recalls / C.R. Bard, Inc., Urological Division / Z-2327-2012

Z-2327-2012 Class II Terminated

Recalled by C.R. Bard, Inc., Urological Division — Covington, GA

Recall Details

Product Type: Devices
Report Date: September 19, 2012
Initiation Date: June 29, 2012
Termination Date: February 7, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56,694 units

Product Description

Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

Reason for Recall

Incomplete seal on sterile packages of product.

Distribution Pattern

Nationwide distribution: USA

Code Information

Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)