Bard Foley procedural trays packaged in breather bags — Class II medical device recall Z-2327-2012
Terminated recall by C.R. Bard, Inc., Urological Division, reported 2012-09-19, distributed nationwide. Incomplete seal on sterile packages of product.
| Recall number | Z-2327-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Urological Division, Covington, GA, United States |
| Recall initiated | 2012-06-29 |
| Classified | 2012-09-07 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 56,694 units |
| Reason classes | sterility, packaging |
| Lot numbers | NGVJ1105, NGVJ1108, NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617, NGVJ1705, NGVJ1712, NGVJ1713, NGVJ1714, NGVJ1757, NGVJ1764 |
| Model numbers | 300316A, 897414, 898316, 907600, 907618 |
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 for recall
Incomplete seal on sterile packages of product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2327-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.