Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be assured, creating a risk of infection or harm during invasive procedures. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 206 boxes of the CIVCO Tracking Bracket Starter Kit, REF 667-132. The product is a reusable, non-sterile PercuNav tracking bracket with Infiniti Plus needle guides (12, 14, 16, 18GA) used in needle-guided or catheter procedures with diagnostic ultrasound transducers. The recall is being conducted because the sterility of the product cannot be assured.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Australia, Canada, China, France, Germany, Japan, and the United Kingdom. The recall covers specific lot codes, including M093630, M093640, and M093650, among others.
Healthcare providers and facilities should stop using the affected tracking brackets and needle guides. Civco Medical Instruments is the recalling firm responsible for managing the recall.
The recalled product
- Product
- CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound…
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Affected units
- 206
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)
- M093630
- M093640
- M093650
- M128890
- M128930
- M163120
- M191470
- M191880
- M202970
- M205490
- M211000
- M218540
- M218550
- M218560
- M240080
- M250210
- M262470
- M308100
- M328800
- M333890
Distribution
Part of a larger recall action
This product is one of 5 recalled by Civco Medical Instruments Co. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Civco Medical Instruments Co. Inc.
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- HighCivco eTRAX 14G starter kit may misreport needle tip position
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Same hazard · infection risk
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- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
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