Reported Sep 19, 2012 · Terminated

Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are…

C.R. Bard, Inc., Urological Division

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: C.R. Bard, Inc., Urological Division · 8195 Industrial Blvd Ne · Covington, GA · 30014-1497

Is this the product you have?

  • 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.
Lot codes and dates
  • 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)
Amount recalled
56,694 units

Where it was sold

  • Nationwide

Why it was recalled

Incomplete seal on sterile packages of product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 7, 2013 · Data as of Sep 19, 6:11 PM UTC

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