Recalls / —
—#165157
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
- FDA product code
- GBX — Catheter, Irrigation
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot numbers 11740,41771,41772,41773, and 81709.
Why it was recalled
The suction valve may not close properly which could cause continuous suction.
Root cause (FDA determination)
Device Design
Action the firm took
The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product.
Recalling firm
- Firm
- Cardinal Health 200, LLC
- Address
- 3651 Birchwood Dr, Waukegan, Illinois 60085-8337
Distribution
- Distribution pattern
- Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherlands, Singapore, and United Kingdom.
Timeline
- Recall initiated
- 2018-06-11
- Terminated
- 2020-08-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.