Enforcement Report - Week of September 19, 2012
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Event Detail
| Event ID | 62774 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | C.R. Bard, Inc., Urological Division |
| City | Covington |
| State | GA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-29 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | Nationwide distribution: USA |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | 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) | Class II | Incomplete seal on sterile packages of product. | 56,694 units | Z-2327-2012 |
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