FDAFDA · Food and drugs·Recall number Z-2327-2012
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.
Published September 19, 2012 · Recall initiated: June 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incomplete seal on sterile packages of product.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- C.R. Bard, Inc., Urological Division
- Distributor
- Nationwide distribution: USA
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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