Teleflex Medical Recalls Belly Bag Urine Collection Bags Due to Packaging Concerns
Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.
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 2/5 (Moderate).
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. The hazard is a potential compromise of sterile packaging, which is a theoretical risk of contamination without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Teleflex Medical is recalling 190,103 units of the Belly Bag Urine Collection Bag with Hip Belt. This product is a sterile urine collection device designed to collect urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. The recall is being conducted because the sterile packaging may be compromised.
The affected products were distributed worldwide, including in the United States, Singapore, Canada, New Zealand, Germany, Ireland, Japan, and Australia. The recall covers specific catalog numbers B1000, B1000P, and B1000CT, along with a comprehensive list of associated lot codes provided in the official recall documentation.
Healthcare facilities and consumers should stop using the affected products and contact Teleflex Medical for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 190,103
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 (20)
- CATALOG NO. B1000 - 02A1100488
- 02A1100489
- 02A1100490
- 02A1100491
- 02A1100492
- 02A1101420
- 02A1101421
- 02A1102009
- 02A1102010
- 02A1102049
- 02A1102050
- 02A1103180
- 02A1103181
- 02A1103182
- 02A1201862
- 02A1201868
- 02A1201869
- 02A1201870
- 02A1201871
- 02A1202372
Distribution
Distribution scope not specified by the agency.
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