Smiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message
Smiths Medical ASD, Inc. is recalling 20 CADD Solis VIP Ambulatory Infusion Pumps sold in Finland due to a mistranslated error message. The pump's function is unchanged, and no patient injury can occur.
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 source text explicitly states that the pump's function is unchanged and no patient injury can occur, classifying this as a documentation or labeling issue with no risk of harm.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 20 units of the CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15. These devices were sold to the Finnish market. The recall is due to a mistranslated word in a specific error message displayed on the pump.
When a user performs a specific set of key presses, the pump displays a message indicating that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. The message should correctly indicate that the PCA dose is not available because the pump is stopped. The source text states that the function of the pump is unchanged and no patient injury can occur since no drug is being delivered during this specific message display.
The affected units are identified by the following codes: 1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189. Consumers and healthcare providers should contact Smiths Medical ASD, Inc. for further instructions regarding the recall.
The recalled product
- Product
- CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 20
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)
- 1071155
- 1076826
- 1081258
- 1081260
- 1081275
- 1082475
- 1082511
- 1082512
- 1090347
- 1090348
- 1090349
- 1091767
- 1091768
- 1091769
- 1091770
- 1091771
- 1092395
- 1100186
- 1100188
- 1100189.
Distribution
Distribution scope not specified by the agency.
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