Bard Foley procedural trays recalled due to incomplete sterile seals
C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the integrity of the sterile barrier is compromised, but no injuries or illnesses have been reported.
Plain-English summary
C.R. Bard, Inc., Urological Division is recalling 56,694 units of Bard Foley procedural trays. These trays are used to catheterize patients and are sold sterile for single use in Tyvek breather bags. The recall is due to incomplete seals on the sterile packages.
The affected products were distributed nationwide in the United States. The recall includes specific catalog numbers and lot numbers, including Catalog No. 300316A, 898316, 897414, 907618, and 907600.
Healthcare providers and consumers should stop using the affected trays and contact C.R. Bard for further instructions on how to return or dispose of the product.
The recalled product
- 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.
- Manufacturer
- C.R. Bard, Inc., Urological Division
- Category
- Medical Device — Urological
- Affected units
- 56,694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog No. 300316A (Lot Nos. - NGVJ1108
- NGVJ1712
- NGVJ1713
- NGVJ1105
- NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614
- NGVJ1615
- NGVJ1616
Distribution
Distributed nationwide across the United States.
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