Route 92 Medical delivery catheter recalled due to tip separation risk
Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall carries a minimum severity score of 4 per classification guidelines. No illnesses or injuries are reported in the source text.
Plain-English summary
Route 92 Medical Inc is recalling the Tenzing 7 Delivery Catheter (REF 1005), a prescription-only sterile medical device used to guide interventional tools into blood vessels in the neurovasculature.
The recall addresses a potential for the distal tip to separate at the proximal marker band. This defect could affect device function and compromise safety during use.
The recall affects 200 units distributed across the United States and New Zealand. The affected lot numbers are 23033001, 23073101, 23070305, and 23081707.
The recalled product
- Product
- Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Hazard
- tip-separation
- device-malfunction
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 (4)
- UDI: 00853799007534/ Lot # 23033001
- 23073101
- 23070305
- 23081707
Distribution
Distributed in 30 states:
- AL
- AZ
- CA
- DE
- FL
- GA
- IA
- IL
- IN
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- NC
- ND
- NJ
- NY
- OH
- OR
- PA
- RI
- SD
- TN
- TX
- UT
- VA
- WV
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