Z-2327-2012Class II

Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box...

Name: Z-2327-2012 Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box...
Creator: C.R. Bard, Inc., Urological Division
Published: 2012-06-29
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2012-06-29 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc., Urological Division began a recall of 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... on 2012-06-29. FDA classified it as Class II and gives the reason as "Incomplete seal on sterile packages of product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2327-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-29
Posted: 2012-09-07
Terminated: 2013-02-07
Recalling firm: C.R. Bard Inc
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.
Product code: EZC Catheter, Coude
Reason for recall: Incomplete seal on sterile packages of product.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2327-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code EZC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)