C.R. Bard Recalls Toomey Syringes Due to Open Package Seal
C.R. Bard is recalling 15,400 units of 70cc Toomey Syringes because a customer reported an open package seal.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a packaging defect (open seal) rather than a direct contamination or functional failure.
Plain-English summary
C.R. Bard, Inc. is recalling 15,400 units of REF 0038460 Toomey Syringe 70cc Syringes with Catheter Tip and Luer Tip Adapters. The recall was initiated after a customer reported an open package seal on the product. The syringes are intended for resectoscope irrigation, catheter irrigation, and Foley catheter inflation.
The affected product is identified by Lot Number NGZE1190. The units were distributed nationwide in the United States, including the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico.
The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected syringes and contact C.R. Bard for further instructions.
The recalled product
- Product
- REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 15,400
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 Number NGZE1190
Distribution
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