Device 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.
Z-2327-2012
Product summary
- Event
- Event 62774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,694 units
- Official record key
device-enforcement:Z-2327-2012
Official wording
Reason: Incomplete seal on sterile packages of product.
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)
Distribution pattern: Nationwide distribution: USA
Derived failure modes
-
Labeling or packaging
Incomplete seal
-
Sterility assurance
Incomplete seal on sterile packages