Z-2327-2012 Class II Terminated
FDA device recall Z-2327-2012 was initiated by C.R. Bard, Inc., Urological Division on June 29, 2012 and is designated Class II. Reason for recall: Incomplete seal on sterile packages of product. The recall status is terminated (terminated February 7, 2013). Affected quantity: 56,694 units.
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)