Reported Dec 2, 2020 · Terminated
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0,…
Flexicare Medical Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flexicare Medical Ltd. · Cynon Valley Business Park, Mountain Ash · Rhondda Cynon Taff, N/A · N/A
Is this the product you have?
- ProVu Single Use Video Stylet with ET Tube
- Part/Size038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
- Lot codes and dates
4 of 4 products · 30 lot codes
Recalled lot codes, grouped by product number Part Lot 038-990-080U191102901200300486200300539200500068200500069200803210191201567200904316200904319
038-990-075U191102900200100157200300535200300536200300537200402330200402331200402333200402334200402335200402336200402337200403976200404287200500991200500992200501790
038-990-070U201000813201100558
038-990-065U201000808202002462 *Note: product and lot number list updated per 12/23/2020 letter to customers
- Amount recalled
- 2087
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
Using this product could cause serious injury, illness or death — stop using it now.
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