The Recall Desk
ModerateFDA (Devices)·Z-1358-2015·Announced 2015-04-08

Bard Urinary Drainage Bags Recalled for Potential Sterile Barrier Breach

C.R. Bard is recalling specific lots of urinary drainage bags due to a potential breach of the sterile barrier packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a 'potential' breach of sterile packaging without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

C.R. Bard, Inc. is recalling 9,620 units of Bard 100% Latex-Free Urinary Drainage Bags with Anti-Reflux Chamber and Bard EX-Lok Sampling (Product Code 154006). The recall involves Lot Numbers NGYJ0603 and NGYJ1671. The reason for the recall is a potential breach of the sterile barrier packaging.

The affected products were distributed nationwide to the states of AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV, and WA.

Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If these products are found, they should be removed from use and returned to the supplier or the manufacturer as directed.

The recalled product

Product
Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671
Manufacturer
C.R. Bard, Inc.
Affected units
9,620

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 Numbers NGYJ0603 and NGYJ1671

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically: