Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns
Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.
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, and the hazard is a packaging defect (seal integrity) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smiths Medical ASD Inc. is recalling 34,141 units of the Smiths Medical Portex 15mm Double Swivel Connector. The affected products include reference numbers 100/255/150, 100/255/150JP, and 100/255/150 JS. The recall covers specific lot numbers and UDI/DI codes listed in the agency's structured data.
The recall was initiated due to uncertainty in the seal integrity of the sterile packaging. This defect could potentially compromise the sterility of the medical device. The affected units were distributed worldwide.
Healthcare facilities and consumers should stop using the affected products and contact Smiths Medical ASD Inc. for further instructions or a return. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 34,141
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)
- a) REF 100/255/150
- UDI/DI 35019315022399
- Lot Numbers: 4125006
- UDI/DI 35019315010990
- Lot Numbers: 4159808
- 4161750
- UDI/DI 35019315011003
- Lot Numbers: 4131840
- UDI/DI 35019315018156
- Lot Numbers: 4131559
- UDI/DI 35019315022405
- Lot Numbers: 4122011
- 4127688
- b) REF 100/255/150JP
- Lot Numbers: 4089148
- 4107293
- 4122008
- 4147817
- 4138707
- 4159808
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Smiths Medical ASD 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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