Smiths Medical CADD IV Administration Set Recalled for Missing Expiration Date
Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (missing expiration date) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging/documentation problems.
Plain-English summary
Smiths Medical ASD Inc. is recalling 641,070 units of the CADD Blue-Striped IV Administration Set (REF 21-7036-01) in Canada. The product is sterilized using ethylene oxide and is distributed exclusively in Canada.
The recall is due to a regulatory compliance issue where the product labels are missing the expiration date. This omission is considered a regulatory compliance issue for Canada.
Consumers and healthcare facilities in Canada should stop using the affected lots and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 641,070
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)
- Lot No.: 010X47
- 025X47
- 064X46
- 079X48
- 094X46
- 103X46
- 108X49
- 155X40
- 170X47
- 173X47
- 187X49
- 193X45
- 208X40
- 208X45
- 217X46
- 224X46
- 230X44
- 241X40
- 268X40
- 286X40
Distribution
Distribution scope not specified by the agency.
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