RecallRadar

FDA Device recall Z-2327-2012

Bard Foley procedural trays packaged in breather bags

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

AgencyFDA Device
Recall numberZ-2327-2012
ClassificationClass II
Statusterminated
Initiated2012-06-29
Published2012-09-19
Last updated2026-09-13 11:53 UTC
CompanyC R Bard Urological Division
DistributionUS

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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