Device product
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Z-0930-2021
Product summary
- Event
- Event 86443
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,781 cases
- Official record key
device-enforcement:Z-0930-2021
Official wording
Reason: Recalled products do not have FDA approval for sale in the United States.
Code information: All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, 4254546-01.
Distribution pattern: US Nationwide distribution including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA.
Derived failure modes
-
Unknown
Recalled products do not have FDA approval for sale in the United States.