Z-0930-2021 Class II Ongoing
FDA device recall Z-0930-2021 was initiated by Braxton Medical Corporation on September 4, 2020 and is designated Class II. Reason for recall: Recalled products do not have FDA approval for sale in the United States. The recall status is ongoing. Affected quantity: 1,781 cases.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- September 4, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,781 cases
Product Description
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.
Reason for Recall
Recalled products do not have FDA approval for sale in the United States.
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.
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.