Bard Urologist's Tray Recalled Over Incorrect French Size Labeling
C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.
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: FDA Class II recall with no reported illness or injury, but the incorrect French size labeling poses a risk of harm during medical procedures, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray, REF 123400, distributed worldwide including US Nationwide and Canada. The recall is due to cather packaging that may contain the incorrect French size, which could lead to use of the wrong device size during medical procedures.
The affected product is identified by Lot # NGJX2513 and UDI 0081741000294. The distribution includes US states such as AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
Healthcare facilities and users should check their inventory for the affected lot number and immediately quarantine any units found. Contact C.R. Bard Inc for replacement or further instructions. No illnesses or injuries have been reported in connection with this recall.
This is a Class II recall, meaning use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Urological Tray
- Affected units
- 63
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 (1)
- Lot # NGJX2513/UDI: 00801741000294
Distribution
Part of a larger recall action
This product is one of 3 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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