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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Foley procedural trays packaged in breather bags

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  Class 2 Device Recall Bard Foley procedural trays packaged in breather bags see related information
Date Initiated by Firm June 29, 2012
Date Posted September 07, 2012
Recall Status1 Terminated 3 on February 07, 2013
Recall Number Z-2327-2012
Recall Event ID 62774
Product Classification Catheter coude - Product Code EZC
Product 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.
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)
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact Mary Mayo
770-784-6120
Manufacturer Reason
for Recall		 Incomplete seal on sterile packages of product.
FDA Determined
Cause 2		 Process control
Action C. R. Bard Inc, sent a Urgent Product Recall Notification letter dated June 27. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notification is being sent because there is a potential for a limited number of units within the subject lots (noted above) that may contain an open seal of the sterile packages. The issue is visually obvious even before the package is opened. No patient injury or adverse events have been reported. Do not use or further distribute any of the affected products. Once the product affected by tlle recall has been removed from your inventory 1.Fill out the Recall & Effectiveness Check Form. Be sure to state the quantities affected of the recalled product that you have in stock. It is extremely important that we receive this information. 2. Fax the Recall & Effectiveness Check Form to BMD at 1-770-784-6469. The Recall Coordinator will issue you with a Return Authorization (RCL) to facilitate the expedient return and replacement of the product. 3. A mailing label is enclosed for your convenience to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and include the RCL number. All products should be retumed to the following shipping address that is in the letter.
Quantity in Commerce 56,694 units
Distribution Nationwide distribution: USA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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