C.R. Bard Recalls SURESTEP Drainage Bags Due to Latex Mislabeling
C.R. Bard is recalling 5,030 SURESTEP Drainage Bags because they are labeled as latex-free but may contain natural rubber latex.
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 allergen mislabeling on a common allergen (natural rubber latex), which corresponds to a severity score of 3 (High) per the rubric.
Plain-English summary
C.R. Bard, Inc. is recalling 5,030 units of SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile. The product is identified by Product Code A300316A and Lot number NGAV2400.
The recall was initiated because the product is misbranded. It is labeled as "Not made with natural rubber latex," but it may in fact contain natural rubber latex. This discrepancy poses a risk to individuals with latex allergies.
The affected units were distributed in California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, and Washington. Consumers and healthcare providers should stop using the affected product and contact C.R. Bard for further instructions.
The recalled product
- Product
- SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Drainage Bags
- Affected units
- 5,030
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 (2)
- Product Code: A300316A
- Lot number: NGAV2400
Distribution
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