FDA Recalls Covidien Trellis-6 Peripheral Infusion Systems Due to Labeling Error
The FDA is recalling 216 units of the Covidien Trellis-6 Peripheral Infusion System because a manufacturing error caused the balloon inflation ports to be incorrectly labeled.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the…"
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 216 units of the Covidien Trellis-6 Peripheral Infusion System. The affected models are BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. These sterile devices are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The recall was initiated due to a manufacturing error that resulted in the risk of incorrect identification of the proximal and distal balloon inflation ports. Specifically, the distal balloon inflation port was incorrectly labeled as proximal, and the proximal balloon port was incorrectly labeled as distal. This labeling error could lead to improper use of the device.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. A total of 207 units were distributed in the US and 9 units were distributed outside the US. Specific lot numbers for each model are listed in the official recall record. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral…
- Manufacturer
- Covidien
- Category
- Medical Device — Infusion System
- Hazard
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)
- Model BVT608010
- Lot numbers: 9853174
- 9864497
- 9890772
- 9890931
- 9925676
- 9932672
- 9937308
- 9937315
- 9940474
- 9940614
- 9976340
- 9978233
- A001589
- A001740. Model BVT608030
- Lot Numbers: 9853331
- 9887597
- 9887695
- 9887757
- 9932042. Model BVT612010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien 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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