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Recall Observatory FDA recall evidence

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

June 29, 2012

Class II

Product summary

Firm
C.R. Bard, Inc., Urological Division
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

    reason.labeling_packaging · v1.0.0

    Incomplete seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Incomplete seal on sterile packages