FDA Device recall Z-2327-2012
Bard Foley procedural trays packaged in breather bags
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of Bard Foley procedural trays packaged in breather bags by C R Bard Urological Division, citing incomplete seal on sterile packages of product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2327-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-29 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | C R Bard Urological Division |
| Distribution | US |
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.
Reason
Incomplete seal on sterile packages of product.
Identifiers
| code_info | Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ161…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2012%22
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